**Executive Summary:**
This document classifies medical devices pertaining to neurological applications based on risk, as determined by the Central Drugs Standard Control Organization (CDSCO), a body of the Directorate General of Health Services, Government of India. The notice categorizes devices by intended use and assigns a risk class (A, B, C, or D). This classification guides regulatory requirements for these devices.
**Key Points / Main Content:**
* **Classification of Medical Devices:**
* The document classifies various medical devices used in neurology.
* Classification is based on the risk associated with the device's intended use.
* Devices are assigned to one of four risk classes: A, B, C, or D.
* **Device Categories and Risk Classes:**
* **Class A:** Includes devices like analytical non-scalp cutaneous electrodes and cranial trephines, skull plate anvils, skull punches and skullplate screwdrivers, nonpowered neurosurgical instruments, esthesiometers, percussion hammers, pinwheels, tuning forks, ultrasonic scanner calibration test blocks, electroencephalograph testers
* **Class B:** Includes devices like analgesic TENS systems, analytical scalp electrodes and leads, diagnostic somatosensory tactile stimulation systems, electroencephalogram EEG signal spectrum analyzers and electrode lead testers and test signal generators, electromyographs, electronystagmographs, facial nerve locating systems, gait enhancement electrical stimulation systems(external), leukotomes, manual surgical saws, neurosurgical head holder skull clamps and microscopes and ultrasound navigation systems, neuromuscular transmission motion sensors, stereotactic neuronavigation planning systems and transcranial electrical stimulation systems(continuous current and pulsedcurrent)
* **Class C:** Includes devices like autonomic neuropathy heart rate meters, behavioural therapy electrical stimulation systems, brain injury adjunctive interpretive electroencephalograph assessment aids, cerebrospinal fluid manometer, programmer and shunt valve, craniotomy systems, depth electrodes, diagnostic peripheral nerve electrical stimulation systems, diagnostic EEG, ejaculation electrical stimulation systems, electroconvulsive therapy systems, electroencephalograph, epicranial brain electrical stimulation systems, home seizure monitoring systems, intramuscular diaphragmphrenic nerve electrical stimulation system programmer, intranasal cooling systems, invasive physiological monitor devices, nasopharyngeal electrodes, needle electrodes, nerve conduction velocity measurement equipment, neurological endoscope, neurological stereotactic surgery system, neuromuscular transmission electrical skin sensors, neuropsychiatric interpretive electroencephalograph assessment aids, olfactometry systems, photodiode subretinal prosthesis system, scalp clips, vagus nerve electrical stimulation system programmer, cerebro spinal fluid manometers and dura mater sealants
* **Class D:** Includes devices like aneurysm clips, antiseizure psychiatric therapy vagus nerve electrical stimulation systems, atrial cerebrospinal fluid catheter, baremetal intracranial vascular stent, bladderbowel evacuation implantable electrical stimulation systems, brain-responsive electrical stimulation systems, cardiac therapy vagus nerve electrical stimulation systems, cerebral perfusion catheter, comaarousal vagus nerve electrical stimulation systems, cortical electrodes, cranial electrotherapy stimulator, cryogenic surgical device, deep brain electrical stimulation systems, diskectomy system, percutaneous, automatic, extramuscular diaphragmphrenic nerve electrical stimulation system, gait enhancement electrical stimulation system(implantable), human dura mater, implantable pulse generator mesh bag, implantable cerebellar stimulator, implantable diaphragmaticphrenic nerve stimulator, implantable intracerebralsubcortical stimulator for pain relief, implantable neuromuscular stimulator, implantable spinal cord stimulator for bladder evacuation, intracranial pressure monitor device, intramuscular diaphragmphrenic nerve electrical stimulation system, meningeal prosthesis, nerve guide, bioabsorbable(animal derived and synthetic), nonbioabsorbable, rheoencephalograph, scoliosis treatment electrical stimulation system, stereotactic radiosurgical system, tibial nerve percutaneous incontinence control electrical stimulation system, transvenous phrenic nerve electrical stimulation control unit
**Impact Analysis:**
* **Medical Device Manufacturers:**
* *Impact:* Manufacturers need to be aware of the classification of their neurological devices to comply with Indian regulations.
* *Action Required:* Review the classification of their devices and ensure compliance with the corresponding regulatory requirements for that risk class in India.
* **Healthcare Providers:**
* *Impact:* Classification affects device procurement and usage protocols.
* *Action Required:* Understand the risk classifications to inform device selection and usage within their facilities.
* **Regulatory Bodies (e.g., CDSCO):**
* *Impact:* The classification informs regulatory oversight and enforcement activities.
* *Action Required:* Utilize the classifications for device registration, approval, and post-market surveillance.
Key Entities Referenced
Directorate General of Health Services: A government organization under the Government of India.
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
FDA, Bhawan, new Delhi110002: Address of Central Drugs Standard Control Organization, New Delhi, India.
Neurological: Pertaining to the study and treatment of disorders of the nervous system.
vagus nerve: A cranial nerve that interfaces with parasympathetic control of the heart, lungs, and digestive tract.
spinal cord: The main nerve pathway carrying signals between the brain and the body.
cerebrospinal fluid CSF: A clear, colorless body fluid found in the brain and spinal cord.
epilepsy: A neurological disorder characterized by recurrent seizures.
Appendix A
File.No.29/Misc/03/2020-DC (201)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA, Bhawan, new Delhi-110002
Notice
Classification of Medical Devices Pertaining to Neurological
Sr. Risk
Device Name Intended Use
No. Class
Intended to deliver controlled electrical impulses directly to
Analgesic PENS
1 the subcutaneous tissue (i.e., invasively) in the vicinity of a B
system
peripheral nerve as relief of chronic neuropathic pain.
Analgesic TENS Intended to treat pain by transcutaneous electrical
2 B
system simulation on peripheral nerves.
Electrical conductor designed to be attached to the skin
Analytical non-
surface of a patient outside of the hair line (i.e., non-scalp)
3 scalp cutaneous A
to conduct electrical signals to a parent device for
electrode
electrophysiological recording/monitoring.
Intended to conduct electrical signals between a skin
Analytical non- electrode(s) or needle electrode(s) [electrode not included]
4 scalp cutaneous and a device designed for electrophysiological A
lead recording/monitoring [e.g., electromyography (EMG),
evoked potentials (EP), bioelectrical impedance].
Intended to be attached to the scalp surface of a patient to
transmit changes in the electrical potential of various areas
Analytical scalp
5 of the brain for recording/monitoring by a connected parent B
electrode
device [i.e., an electroencephalograph (EEG), sleep, or
evoked potential recording device].
Intended to connect an electroencephalographic
Analytical scalp electrode(s) to an electroencephalographic system to
6 B
lead facilitate the transmission of the electrical signals during
encephalography (EEG).
An aneurysm clip is a device used to occlude an intracranial
7 Aneurysm clip. aneurysm (a balloonlike sac formed on a blood vessel) to D
prevent it from bleeding or bursting
Antiseizure/psych
iatric-therapy
Implantable device intended to apply periodic electrical
vagus nerve
8 stimuli to the vagus nerve to help control seizures and/or to D
electrical
help treat psychiatric disorder symptoms (e.g., depression).
stimulation
system
Atrial Intended to be implanted as the distal component of a
9 cerebrospinal ventriculoatrial shunt to channel cerebrospinal fluid (CSF) to D
fluid catheter the right atrium where it can be absorbed into the body.
Autonomic
Intended to diagnose autonomic nervous system
10 neuropathy heart C
dysfunction (autonomic neuropathy).
rate meterBare-metal
Intended to be implanted into the base or parent artery of an
11 intracranial D
intracranial aneurysm.
vascular stent
Behavioural
Intended in the treatment of obsessive/compulsive
therapy electrical
12 behaviour and drug abuse, by applying electrical C
stimulation
impulse(aversion therapy).
system
Bladder/bowel-
evacuation
Intended to empty the urinary bladder and/or the bowels by
implantable
13 applying electrical stimuli typically to the cone-shaped end D
electrical
of the spinal cord (conus medularis).
stimulation
system
A brain injury adjunctive interpretive electroencephalograph
Brain injury assessment aid is a prescription device that uses a patient's
adjunctive electroencephalograph (EEG) to provide an interpretation of
interpretive the structural condition of the patient's brain in the setting of
14 C
electroencephalo trauma. A brain injury adjunctive interpretive EEG
graph assessment aid is for use as an adjunct to standard clinical
assessment aid. practice only as an assessment aid for a medical condition
for which there exists other valid methods of diagnosis
Brain-responsive
Intended to continuously monitor brain activity and deliver
electrical
15 electrical stimuli to seizure foci in response to neurological D
stimulation
disorders (e.g., epilepsy).
system
Cardiac-therapy
vagus nerve
Intended to apply periodic stimuli to the vagus nerve as a
16 electrical D
treatment for cardiac failure.
stimulation
system
Cerebral
Intended for brain protection during profound hypothermic
17 perfusion D
circulatory arrest during aortic surgery.
catheter
Cerebrospinal Intended to measure the cerebrospinal fluid (CSF)
18 C
fluid manometer, pressure/intracranial pressure via lumbar puncture.
Cerebrospinal Intended to noninvasively modify the operating pressure of
19 fluid shunt valve a programmable, non-active, implanted cerebrospinal fluid C
programmer (CSF) shunt valve that is part of a CSF shunt.
Coma-arousal
vagus nerve Intended to apply periodic stimuli to the vagus nerve for the
20 electrical purpose of exciting the patient to arousal from a vegetative D
stimulation state (i.e., a deep coma).
system
A cortical electrode is an electrode which is temporarily
Cortical
21 placed on the surface of the brain for stimulating the brain D
electrode.
or recording the brain's electrical activityIntended to fit into an appropriate powered handpiece that
22 Cranial bur, provides the rotation allowing the user to excavate soft or A
hard skull tissue.
Cranial A cranial electrotherapy stimulator is a device that applies
23 electrotherapy electrical current to a patient's head to treat insomnia, D
stimulator. depression, or anxiety
Metallic rotary endpiece designed to cut a hole(s) or a
24 Cranial perforator circular section(s) of the skull vault (calvarium) by attaching B
to powered drill/handpiece.
Intende as a neurosurgical blade used to cut/remove
25 Cranial trephine, circular sections of the skull vault (calvarium) to provide A
access to the interior
Craniotomy
Intended to be used to rotate a cranial cutting tool (i.e., a
power tool
26 drill bit, bur, trephine or perforator) in order to produce a C
system
hole or holes in the skull vault (calvarium).
handpiece
A cryogenic surgical device is a device used to destroy
Cryogenic
27 nervous tissue or produce lesions in nervous tissue by the D
surgical device.
application of extreme cold to the selected site
A cutaneous electrode is an electrode that is applied directly
Cutaneous
28 to a patient's skin either to record physiological signals (e.g., B
electrode.
the electroencephalogram) or to apply electrical stimulation
Deep brain Designed to apply electrical stimuli to specific areas of the
electrical deep brain for the treatment of movement disorders,
29 D
stimulation psychiatric disorders and/or to treat chronic, severe,
system intractable pain.
Deep brain
electrical Intended to be implanted in specific areas of the deep brain
30 C
stimulation and used along with deep brain electrical simulation system.
system lead
A depth electrode is an electrode used for temporary
31 Depth electrode. stimulation of, or recording electrical signals at, subsurface C
levels of the brain
Diagnostic
peripheral nerve Intended to apply electrical stimuli in one peripheral region
32 electrical of the body while the response is monitored in another C
stimulation peripheral region.
system
Diagnostic Intended to be used to apply tactile stimuli to the body (e.g.,
somatosensory pneumatic activation of a membrane to the fingers and lips)
33 B
tactile stimulation typically for evoked response procedures to investigate the
system function and potential disorders of the brain.
Diskectomy
system, Intended for the percutaneous (through the skin) removal of
34 D
percutaneous, the nucleus pulposus from the lumbar disc.
automatic
Dura mater Intended to be applied to sutured dura mater to prevent
35 C
sealant cerebrospinal fluid (CSF) leakage during healing.An echoencephalograph is an ultrasonic scanning device
Echoencephalogr (including A-scan, B-scan, and doppler systems) that uses
36 C
aph. noninvasive transducers for measuring intracranial
interfaces and blood flow velocity to and in the head
Ejaculation
electrical Intended to apply electrical stimuli to the nerves that control
37 C
stimulation ejaculation.
system
Intended to apply strong electrical stimuli to a patient's
Electroconvulsive
38 brain to induce convulsions and loss of consciousness, C
therapy system
typically to treat major depression, schizophrenia, or mania.
Electroencephalo
An electroencephalogram (EEG) signal spectrum analyzer
gram (EEG)
39 is a device used to display the frequency content or power B
signal spectrum
spectral density of the electroencephalogram (EEG) signal
analyzer.
An electroencephalograph electrode/lead tester is a device
Electroencephalo
used for testing the impedance (resistance to alternating
graph
40 current) of the electrode and lead system of an B
electrode/lead
electroencephalograph to assure that an adequate contact
tester.
is made between the electrode and the skin
Electroencephalo
An electroencephalograph test signal generator is a device
41 graph test signal B
used to test or calibrate an electroencephalograph
generator.
Intended to perform quality control procedures on an
Electroencephalo
42 electroencephalograph (EEG) machine and/or a sleep A
graph tester
recording machine.
An electroencephalograph is a device used to measure and
Electroencephalo
43 record the electrical activity of the patient's brain obtained C
graph.
by placing two or more electrodes on the head
Electroencephalo
Analytical scalp electrodes preconfigured within a head-
44 graphic electrode B
worn device to use with electroencephalography (EEG).
cap
Electroencephalo Intended to continuously record electroencephalographic
graphic long-term signals in ambulatory patients for periods usually from 24 to
45 B
ambulatory 72 hours to assess a variety of neurological conditions (e.g.,
recorder epilepsy) and psychiatric disorders.
Intended to continuously measure the electrical signals
produced by a patient's brain and display/record them as an
Electroencephalo electroencephalogram (EEG) to evaluate brain function.
graphic Alongwith which measuring of other physiological
46 C
monitoring parameters such as electromyogram (EMG), respiration
system wave forms, blood pressure, ocular motility, and/or
haemoglobin oxygen saturation (SpO2) and carbon dioxide
(CO2) in relation to EEG.
Intended in clinical diagnosis of muscular disorders to
evaluate muscle weakness and to determine if the
47 Electromyograph B
weakness is related to the muscles themselves or a
problem with the nerves that supply the muscles.
Electronystagmo Intended for detecting the electrical potential caused by eye
48 B
graph movements.Epicranial brain
Intended to apply weak, pulsed (not continuous) electrical
electrical
49 stimuli from beneath the scalp to specific areas of the brain C
stimulation
for the treatment of focal epilepsy.
system
An esthesiometer is a mechanical device which usually
consists of a single rod or fiber which is held in the fingers of
50 Esthesiometer. A
the physician or other examiner and which is used to
determine whether a patient has tactile sensitivity
Intended to provide ventilatory support to a patient with
Extramuscular
diaphragm dysfunction of neuromuscular origin through
diaphragm/phreni
electrical stimulation of the phrenic nerve, to contract the
51 c nerve electrical D
diaphragm rhythmically (using extramuscular electrodes)
stimulation
and cause the patient to draw breath in a manner similar to
system
natural breathing.
Facial nerve Intended to locate a facial nerve by applying an electrical
52 B
locating system stimulus.
Gait-
Intended to improve the gait in a patient suffering from
enhancement
partial paralysis of the lower extremities or other
53 electrical B
neuromuscular disorders by applying external electrical
stimulation
simulation.
system, external
Gait-
enhancement Intended to improve the gait in a patient suffering from
electrical partial paralysis of the lower extremities or other
54 D
stimulation neuromuscular disorders by applying internal electrical
system, simulation.
implantable
Intended to detect and record a seizure by continuous
measurement of one or more physical/physiological
Home seizure
parameters (e.g., body motion, electrical activity of the heart
55 monitoring C
or skeletal muscles) in a patient with epilepsy during daily
system
activities and/or sleep in the home; some types may also be
used in clinical settings.
Human dura Human dura mater is human pachymeninx tissue intended
56 D
mater. to repair defects in human dura mater
Implantable pulse Intended to envelop an implantable pulse generator (IPG)
generator mesh (e.g., cardiac pacemaker/defibrillator, neurostimulator) to
57 D
bag, stabilize the implant in the subcutaneous pocket in which it
bioabsorbable is implanted.
Implantable
spinal cord Device designed to change, telemetrically, one or more of
electrical the operating parameters (the programs) of an implanted
58 C
stimulation spinal cord electrical stimulation system pulse generator
system (EPG).
programmer
An implanted cerebellar stimulator is a device used to
stimulate electrically a patient's cerebellar cortex for the
treatment of intractable epilepsy, spasticity, and some
Implanted
movement disorders. The stimulator consists of an
59 cerebellar D
implanted receiver with electrodes that are placed on the
stimulator.
patient's cerebellum and an external transmitter for
transmitting the stimulating pulses across the patient's skin
to the implanted receiverAn implanted diaphragmatic/phrenic nerve stimulator is a
device that provides electrical stimulation of a patient's
phrenic nerve to contract the diaphragm rhythmically and
produce breathing in patients who have hypoventilation (a
Implanted
state in which an abnormally low amount of air enters the
diaphragmatic/ph
60 lungs) caused by brain stem disease, high cervical spinal D
renic nerve
cord injury, or chronic lung disease. The stimulator consists
stimulator.
of an implanted receiver with electrodes that are placed
around the patient's phrenic nerve and an external
transmitter for transmitting the stimulating pulses across the
patient's skin to the implanted receiver
An implanted intracerebral/subcortical stimulator for pain
relief is a device that applies electrical current to subsurface
Implanted
areas of a patient's brain to treat severe intractable pain.
intracerebral/sub
61 The stimulator consists of an implanted receiver with D
cortical stimulator
electrodes that are placed within a patient's brain and an
for pain relief.
external transmitter for transmitting the stimulating pulses
across the patient's skin to the implanted receiver
An implanted neuromuscular stimulator is a device that
provides electrical stimulation to a patient's peroneal or
femoral nerve to cause muscles in the leg to contract, thus
improving the gait in a patient with a paralyzed leg. The
Implanted
stimulator consists of an implanted receiver with electrodes
62 neuromuscular D
that are placed around a patient's nerve and an external
stimulator.
transmitter for transmitting the stimulating pulses across the
patient's skin to the implanted receiver. The external
transmitter is activated by a switch in the heel in the
patient's shoe
An implanted spinal cord stimulator for bladder evacuation
is an electrical stimulator used to empty the bladder of a
paraplegic patient who has a complete transection of the
Implanted spinal spinal cord and who is unable to empty his or her bladder by
cord stimulator reflex means or by the intermittent use of catheters. The
63 D
for bladder stimulator consists of an implanted receiver with electrodes
evacuation. that are placed on the conus medullaris portion of the
patient's spinal cord and an external transmitter for
transmitting the stimulating pulses across the patient's skin
to the implanted receiver
Intracranial Intended for intermittent or continuous measurement and
64 pressure monitor display of intracranial pressure (ICP). It is used in D
device conjunction with an invasive intracranial device.
Intended to provide ventilatory support to a patient with
Intramuscular
diaphragm dysfunction of neuromuscular origin through
diaphragm/phreni
electrical stimulation of the phrenic nerve to contract the
65 c nerve electrical D
diaphragm rhythmically (using intramuscular electrodes) and
stimulation
cause the patient to draw breath in a manner similar to
system
natural breathing.Intramuscular
diaphragm/phreni Intended to change, telemetrically, one or more of the
c nerve electrical operating parameters (the programs) of an intramuscular
66 C
stimulation diaphragm/phrenic nerve electrical stimulation system
system external pulse generator (EPG).
programmer
Intended for rapid cooling induction in patients where
Intranasal cooling temperature reduction is clinically indicated (e.g., following a
67 C
system cerebral ischemic event, during cardiac arrest) to help
mimimize damage to the brain and heart.
Invasive- Intended for continuous or intermittent measurement,
detection display and/or recording of several invasively-detected
68 C
physiological physiological parameters [e.g., intracranial pressure (ICP),
monitor compartmental pressure].
Intended to cut brain tissue (i.e., cutting white matter,
69 Leukotome B
leukotomy).
Intended to non-invasively detect, measure, and display bio-
magnetic signals produced by electrically-active cortical
Magnetoencepha
70 brain tissue, and that provide diagnostic information about B
lography system
the location of the active tissue responsible for cognitive
brain functions relative to the surrounding brain anatomy
Manual surgical Intended for cutting bone through a sawing action during
71 B
saw, flexible neurological or orthopaedic surgery.
Meningeal
72 Intended to repair the meningeal membrane (meninges). D
prosthesis
A nasopharyngeal electrode is an electrode which is
Nasopharyngeal
73 temporarily placed in the nasopharyngeal region for the C
electrode.
purpose of recording electrical activity
A needle electrode is a device which is placed
74 Needle electrode. C
subcutaneously to stimulate or to record electrical signals
A nerve conduction velocity measurement device is a
Nerve conduction device which measures nerve conduction time by applying a
velocity stimulus, usually to a patient's peripheral nerve. This device
75 C
measurement includes the stimulator and the electronic processing
device. equipment for measuring and displaying the nerve
conduction time
Nerve guide, Collagen matrix material intended to be used to create a
76 bioabsorbable, tunnel through which a discontinuous peripheral nerve can D
animal-derived regenerate to bridge the proximal and distal nerve stumps.
Nerve guide, Synthetic material intended to be used to create a tunnel
77 bioabsorbable, through which a discontinuous peripheral nerve can D
synthetic regenerate to bridge the proximal and distal nerve stumps.
Non-bioabsorbable material intended to be used to create a
Nerve guide, non-
78 tunnel through which a discontinuous peripheral nerve can D
bioabsorbable
regenerate to bridge the proximal and distal nerve stumps.
Neurological A neurological endoscope is an instrument with a light
79 C
endoscope. source used to view the inside of the ventricles of the brainNeurological
Intended to store diagnostic images used for image-guided
80 stereotactic C
neurosurgery.
surgery system
Neuromuscular
Intended to detect electrical neuromuscular transmission
transmission
81 (NMT) signals, for assessing the degree of neuromuscular C
electrical skin
block in a patient.
sensor
Intended to be placed on the thumb and index finger of a
Neuromuscular
patient to detect movements and convert them into
82 transmission B
electrical neuromuscular transmission (NMT) signals during
motion sensor
nerve stimulation.
The neuropsychiatric interpretive electroencephalograph
Neuropsychiatric assessment aid is a prescription device that uses a patient's
interpretive electroencephalograph (EEG) to provide an interpretation of
83 electroencephalo the patient's neuropsychiatric condition. The C
graph neuropsychiatric interpretive EEG assessment aid is used
assessment aid. only as an assessment aid for a medical condition for which
there exists other valid methods of diagnosis
Neurosurgical Intended to support and position a patient in a sitting or
84 A
chair reclined position during neurosurgery.
Neurosurgical A neurosurgical head holder (skull clamp) is a device used
85 head holder (skull to clamp the patient's skull to hold head and neck in a B
clamp). particular position during surgical procedures
Neurosurgical A neurosurgical headrest is a device used to support the
86 A
headrests. patient's head during a surgical procedure
Designed to magnify minute structures within the
neurological fields for surgery, typically the brain or spine or
Neurosurgical
87 surroundings in the performance of neurological surgical B
microscope
procedures which require high magnification by transmitted
light.
Neurosurgical
Intended for intraoperative imaging of the brain for precise
ultrasound
88 navigation during brain surgery (e.g., resection of malignant B
navigation
brain tumours, treatment of vascular malformations).
system
Non-
electroencephalo
A non-electroencephalogram (non-EEG) physiological
gram (EEG)
signal based seizure monitoring system is a noninvasive
physiological
89 prescription device that collects physiological signals other C
signal based
than EEG to identify physiological signals that may be
seizure
associated with a seizure
monitoring
system.
A nonpowered neurosurgical instrument is a hand
instrument or an accessory to a hand instrument used
Nonpowered during neurosurgical procedures to cut, hold, or manipulate
90 neurosurgical tissue. It includes specialized chisels, osteotomes, curettes, A
instrument. dissectors, elevators, forceps, gouges, hooks, surgical
knives, rasps, scissors, separators, spatulas, spoons,
blades, blade holders, blade breakers, probes, etc
Olfactometry Intended to determine the response of humans to odours
91 C
system delivered through the nose, including irritants.Percussion Intended to be used by an examining physician to gently tap
92 A
hammer, manual near a patient's joints to test reflexes.
A percussor is a small hammerlike device used by a
93 Percussor. physician to provide light blows to a body part. A percussor A
is used as a diagnostic aid during physical examinations
Photodiode Designed to provide visual function to a patient with vision
subretinal loss due to retinal degeneration by detecting light,
94 C
prosthesis converting it into electrical signals, and relaying them to the
system retina for neural stimulation.
Physical therapy
ultrasound/neuro Designed to produce a rhythmic contraction/release of
95 muscular injured muscles to promote the removal of metabolic by- B
stimulation products while applying ultrasound treatments.
system
A pinwheel is a device with sharp points on a rotating wheel
96 Pinwheel. A
used for testing pain sensation
A rheoencephalograph is a device used to estimate a
Rheoencephalogr patient's cerebral circulation (blood flow in the brain) by
97 D
aph. electrical impedance methods with direct electrical
connections to the scalp or neck area
A scalp clip is a plastic or metal clip used to stop bleeding
98 Scalp clip. C
during surgery on the scalp
Scoliosis-
treatment Intended to apply electrical stimuli to the spinal musculature
99 electrical to produce a force that stabilizes or limits the progression of D
stimulation the spinal lateral curvature (i.e., scoliosis).
system
A skull plate anvil is a device used to form alterable skull
100 Skull plate anvil. plates in the proper shape to fit the curvature of a patient's A
skull
A skull punch is a device used to punch holes through a
101 Skull punch. patient's skull to allow fixation of cranioplasty plates or bone A
flaps by wire or other means
A skullplate screwdriver is a tool used by the surgeon to
Skullplate
102 fasten cranioplasty plates or skullplates to a patient's skull A
screwdriver.
by screws
Intended to receive and analyse patient magnetic
resonance imaging (MRI) images and position landmarks on
Stereotactic these images, then register the images by the mean of a
103 neuronavigation/ three-dimensional (3-D) optical positioning system B
planning system (frameless stereotactic neuronavigation) to provide real-time
relative positioning for the treatment probes and
instruments.
Intended to deliver a therapeutic radiation dose to an
Stereotactic anatomical region from external beams produced from
104 radiosurgical multiple radionuclide sources arranged in a fixed focal point D
system collimated array; typically used to treat brain, neck, breast
and spinal tumours.Tibial nerve
percutaneous
Intended to treat urinary and/or faecal incontinence with
incontinence-
105 electrical stimuli applied to the sacral nerve via D
control electrical
percutaneous tibial nerve stimulation (PTNS).
stimulation
system
Transcranial Intended for one or more psychiatric\neurological therapy
electrical types [e.g., transcranial direct current stimulation (tDCS),
stimulation transcranial alternating current stimulation (tACS)]. And to
106 system, induce a state resembling that of chemically-induced B
continuous- anaesthesia for treating one or more psychiatric disorders
current and which may include anxiety, depression, insomnia, and/or
pulsed-current addiction.
Transvenous
Intended to configure/deliver stimulation of the phrenic
phrenic nerve
nerve, via a transvenous electrode, to cause contraction of
107 electrical D
the diaphragm in conjunction with mechanical ventilation to
stimulation
assist earlier ventilation weaning.
control unit
Intended to test the hearing acuity of a patient, to diagnose
108 Tuning fork A
hearing disorders, and to test for vibratory sense.
Ultrasonic
An ultrasonic scanner calibration test block is a block of
scanner
109 material with known properties used to calibrate ultrasonic A
calibration test
scanning devices (e.g., the echoencephalograph)
block.
Vagus nerve
electrical
The strength and duration of the electrical impulses are
110 stimulation C
programmed
system
programmer