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Appendix A
File No. 29/Misc/03/2020-DC(178)
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
Notice
Classification of Medical Devices Pertaining to Pain Management
Sr. Risk
Medical Device Name Intended Use
No Class
A device designed to be worn on the wrist(s) for the application of
1 Acupressure wristband pressure to the Nei-kuan (P6) acupressure point, the area identified A
to help relieve the sensation of nausea.
Acupuncture electrical An assembly of devices used to apply electrical stimuli to
2 B
stimulation system acupuncture sites.
A collection of instruments and supplies used to perform
3 Acupuncture kit B
acupuncture procedures.
Acupuncture point An electronic probe used to precisely locate an acupuncture point
4 B
detector on a patient's body.
Analgesic spinal cord
An assembly of devices that applies an electrical stimulus to all or
5 electrical stimulation C
part of the spinal cord to relieve pain (analgesia).
system
A thin, plastic, horshoe-like wafer that is placed between the upper
6 Bite relief pad and lower sets of teeth and bitten down on, or chewed, to help A
relieve pain or discomfort after orthodontic treatment.
A device designed to provide analgesia by applying extremely low
7 Cryogenic analgesia unit temperatures to body tissues. It is used for postoperative and C
chronic intractable pain relief.
An instrument used in auriculotherapy to apply continuous pressure
8 Ear microsystem needle A
to stimulate meridian points.
Electric pad localized-body An assembly of devices designed for the transcutaneous application
9 B
heating system of heat to a localized body site to relieve musculoskeletal pain.
A device intended to be applied with pressure to the body surface to
Endothermic cold therapy
10 provide cold therapy to help reduce fever, pain, and inflammation B
pack
associated with joint/muscle/tissue injury and/or minor burns.
A device designed to be filled with water to provide therapeutic heat
11 Foot bath treatment specifically to the feet. This device is intended to relieve A
foot pain as well as headaches, coughs, and other cold symptoms.
A non-sterile gelatinous compound in a container that is dispensed
for application to the body surface to provide a warming effect for
12 Heat therapy gel underlying tissues. It is intended to reduce/relieve pain, muscle A
tension, and to increase local circulation.(Not in direct contact with
tissue)
Intended to alleviate pain and/or promote healing in minor injuries of
13 Ice bag A
the body or for application around the neck or limbs.
Page 1 of 2Intended to alleviate pain and/or promote healing in minor injuries of
14 Ice collar A
the neck, throat, and/or head and to alleviate a sore throat.
A device designed to be implanted in a patient for the storing and
Implantable intrathecal subarachnoid (intrathecal) administration of narcotics/drugs to
15 D
infusion pump manage intractable pain and muscle spasms of malignant or non-
malignant origin.
Implantable lumbar The system is designed to deliver episodic electrical stimulation to
16 neuromuscular electrical nerves that innervate lumbar muscles to elicit contraction for the D
stimulation system treatment of chronic low back pain (CLBP).
A assembly of devices intended for localized thermal and
Inflatable hot/cold therapy
17 compression therapy to facilitate the treatment of a variety of B
pack/electric pump
adverse conditions resulting from musculoskeletal injury.
A device primarily designed to administer analgesic gases to the
18 Inhalational analgesia unit B
patient, or produce analgesic vapours for inhalation.
A device intended to be applied to the skin overlying an affected
Intervertebral disc
19 area of the spine (cervical or lumbar) to reduce pain associated with B
prolapse therapy pack
a prolapsed (herniated) intervertebral disc.
A device designed to fit over the upper and lower sets of teeth to
20 Intubation teeth protector protect them from damage during endotracheal (ET) tube intubation A
procedures.
A fixed framework with a tilting table platform designed to support
the body of a patient and provide traction for the back muscles and
21 Inversion table spine by allowing the patient manually invert their entire body in a A
supine position (feet up and head down), thereby assist patients
eliminate/alleviate back pain.
22 Massage table/couch A table designed for various kinds of complementary therapy. A
An assembly of devices designed to monitor and provide electrical
stimuli to spinal nerves or other neural pathways during
Neurophysiologic
23 intraoperative surgery or intensive care, typically to reduce the C
monitoring system
incidence of accidental injury during instrumented spine surgery, or
to diagnose acute dysfunction in corticospinal conduction.
A skin patch designed to reflect the naturally emitted infrared energy
Pain-relief phototherapy back into the body, with a reduced range of wavelength, intended to
24 B
skin patch provide comfort and localized temporary relief of body aches and
pains by phototherapeutic stimulation of strategic points on the skin.
A tub filled with water, that is heated by its heating elements and
circulated by its agitators, intended for use in external hydrotherapy
25 Sitz bath A
to relieve pain or pruritus and to accelerate the healing of inflamed
or traumatized tissues of the perianal and perineal areas.
A device designed to be sat upon by a patient in a powered sitz bath
for external hydrotherapy to relieve pain or pruritus and to
26 Sitz bath chair A
accelerate the healing of inflamed or traumatized tissues of the
perianal and perineal areas.
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