Appendix-A
File No. 29/Misc./03/2020-DC (160)
Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi
Notice
Classification of Medical Devices Pertaining to Rehabilitation
Classification
India
Name of the
S.No Intended use as per First
Medical Device
Schedule part-
1 MDR 2017
Intended to wear around the calf to apply
pressure to an acupressure point to relieve
Acupressure calf Class A
1 low back pain, including sciatica and
band
piriformis syndrome. A Non powered belt
like device.
Intended to be used as adjunctive therapy
in reducing the level of pain and stiffness
Arthritis TENS associated with rheumatoid arthritis or Class B
2
system osteoarthritis by electrically stimulating
peripheral nerves across the skin
(transcutaneous).
Intended to strengthen the muscles of the
back (especially the latissimus dorsi)
Back pulldown Class A
3 through a repetitive pulldown motion
exerciser
performed with the arms against the force
of a weight.
intended to strengthen the muscles of the
back through a repetitive rowing motion (as Class A
4 Back row exerciser
in rowing a boat with oars) performed with
the arms against the force of a weight.
Powered device intended to assess
Back/leg/chest
neuromuscular function by measuring the Class B
5 dynamometer,
force or power exerted by the back, chest,
electronic
and/or leg muscles during flexion.
Non powered device intended to assess
Back/leg/chest
neuromuscular function by measuring the Class A
6 dynamometer,
force or power exerted by the back, chest,
mechanical
and/or leg muscles during flexion.
Intended to be used as an unstable
Balance ball Class A
7 surface on which to perform exercise to
exerciser
improve balance and posture.
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Intended to provide biofeedback for
training of balance by sensing body
movements and subsequently producing
Balance-training
signals which are translated into electrical Class B
8 tongue electrical
stimuli applied to the tongue, enabling a
stimulation system
patient to correlate electrotactile
stimulation with their head and body
position during exercise sessions.
Intended to provide therapeutic massage
Bed/chair electric Class B
9 to the occupant of a bed or chair for the
massager
treatment of body aches and pains.
Intended to be used to provide a
quantitative measurement of the rate at
Class A
10 Bicycle ergometer which work (energy) is performed by a
muscle or group of muscles under
controlled conditions.
Intended to initiate urination and facilitate
complete bladder emptying through
Bladder-emptying Class B
11 application of small mechanical vibrations
vibratory stimulator
to the lower abdomen to promote urethral
sphincter relaxation.
Intended to emit blue light, red light, and
infrared radiation (heating effect) for
Blue/red/infrared phototherapy treatment of mild skin Class A
12
phototherapy lamp disorders (e.g., mild acne), superficial skin
wounds, and musculoskeletal symptoms
(e.g., pain, spasm, stiffness).
Intended to primarily strengthen several or
all of the major muscle groups of the body
Body elastic Class A
13 (i.e., in the arms, legs, chest, back, and/or
exerciser
abdomen) through repetitive body motion
against elastic resistance.
Intended to strengthen several of the major
Body flywheel muscle groups of the body (i.e., in the Class A
14
exerciser arms, legs, chest, back) through repetitive
body motion against a flywheel.
Intended to be used to pump heated
and/or cooled fluid (e.g., water) through
Circulating-fluid externally applied packs for localized hot
Class B
15 thermal therapy and/or cold therapy to help treat a variety
system of adverse conditions resulting from
musculoskeletal injury (e.g., pain, swelling,
inflammation).
Intended to facilitate, through cooling and
Cold compression compression, the treatment of a variety of
Class A
16 therapy cervical conditions resulting from injury/surgery to
spine collar the neck region (e.g., inflammation,
stiffness, whiplash).
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intended for localized topical skin
Cold/cool therapy application to provide a cooling effect for Class A
17
gel underlying muscles/joints to reduce pain
and swelling.
Intended to reduce localized
pain/inflammation, and/or to reduce
Cold-air therapy Class B
18 thermal skin damage by applying cold
unit
stream of air during dermatological laser
treatments.
Intended to enable a patient with a lumbar
spine injury to perform controlled
Core-body
extension, contraction, and/or twisting Class A
19 mechanical weight
movements of the lumbar/thoracic spine
exerciser
back region and the abdomen, for testing
and rehabilitation.
Intended to apply an electromagnetic (EM)
field to body tissues to: 1) treat
musculoskeletal disorders (e.g.,
Deep-tissue
osteoarthritis, osteoporosis); 2) treat body Class B
20 electromagnetic
pain (musculoskeletal, postsurgical);
stimulation system
and/or 3) help facilitate soft and hard tissue
wound/injury healing, with no production of
a therapeutic deep heat.
Intended for respiratory therapy or
physiotherapy (e.g., help reduce muscular Class B
21 Electric massager
tension, arthritic pain or joint mobility) in
the home and/or healthcare facility.
Electromechanical
Intended to provide electromechanical
orthopaedic
orthopaedic extracorporeal shock wave Class C
22 extracorporeal
therapy (OEST) to treat musculoskeletal
shock wave therapy
disorders.
system
Intended to evaluate a patient’s range of
motion/movement of individual
Electronic
joints/limbs/spine; it is used in a clinical Class B
23 goniometer/kinesiol
setting typically before/after a
ogy sensor
medical/surgical intervention, or to assess
degree of physical fitness.
Intended to be applied to the body surface,
sometimes with pressure, to provide heat
Exothermic heat Class A
24 therapy to reduce muscle spasms and
therapy pack
cramps and/or for joint and muscle
stiffness and pain.
intended primarily to strengthen the
Finger/hand muscles of the fingers and hands through Class A
25
exerciser repetitive finger/hand motion against
resistance from elasticity or density.
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Intended to provide non-invasive
peripheral neurostimulation to the feet for
Foot sensorimotor improving somatosensory integration,
Class C
26 therapy mechanical typically for reducing motor impairments
neurostimulator and balance disturbances in patients with
neurological or neurodegenerative
disorders (e.g., Parkinson's disease).
Gait analysis Intended to be used to study walking or Class A
27
system running patterns.
Electronic device intended to assess
Hand neuromuscular function by measuring the
Class B
28 dynamometer/pinch force or power exerted by the muscles of
meter, electronic the hand/forearm to squeeze/pinch an
object.
Mechanical device intended to assess
Hand neuromuscular function by measuring the
Class A
29 dynamometer/pinch force or power exerted by the muscles of
meter, mechanical the hand/forearm to squeeze/pinch an
object.
Powered device intended for use in
partially immersed in water, e.g., in a
Hydrotherapy hydrotherapy tank, to provide additional Class A
30
treadmill resistance to the treadmill walking exercise
without increasing the impact and/or stress
on the patient's joints.
Intended to stimulate peripheral nerves
through the transcutaneous application of
Interferential
two currents of slightly different Class C
31 electrical
frequencies that cross-over/interfere,
stimulation system
producing a beating frequency at the
treatment point.
Non powered device intended to be used
in a clinical setting to measure the range of
Class A
32 Manual goniometer motion of the limb of a patient by
measuring the angle of movement
achieved at the joint.
Intended to produce a therapeutic deep
Medium-wave heat within specific volumes of the body
Class B
33 diathermy treatment through the transcutaneous transmission of
system electromagnetic (EM) energy in the radio-
frequency (RF) bands of 0.5 MHz to 1 MHz
Intended to produce a therapeutic heat 1 to
2 cm below the skin within specific
volumes of the body through the
Microwave
transcutaneous transmission of high Class B
34 diathermy treatment
frequency electromagnetic (EM) energy,
system
typically 2,450 megahertz (MHz)
[microwave], to promote tissue healing and
pain relief.
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Intended to provide a source of infrared
(IR) heat for localized treatment of
Musculoskeletal
musculoskeletal pain/injury (e.g., muscle Class B
35 infrared
pain, sports injury, rheumatism) and to
phototherapy unit,
improve blood circulation in the treated
areas to facilitate healing.
Intended to produce and deliver intense
Musculoskeletal therapeutic ultrasound (ITU) waves
Class C
36 intense therapeutic through the skin to create ablative lesions
ultrasound system in subcutaneous soft tissues (e.g.,
muscles, tendons).
Intended to provide noninvasive laser
therapy [e.g., infrared phototherapy, low-
level laser therapy (LLLT)] for localized
Musculoskeletal/ treatment of musculoskeletal conditions
Class C
37 physical therapy (e.g., muscle pain, sports injury, disorders
laser of the joints and soft/connective tissues),
improving blood circulation in the treated
areas to facilitate healing, or for non-
needle acupuncture.
Intended to assist users in maintaining
good walking posture, particularly a person
Parallel bar Class A
38 with a disability, a paraplegic, or a patient
exerciser,
who has suffered a stroke and is learning
to walk.
Electrically powered device intended to
Physical therapy Class B
39 provide therapeutic massage to a larger
massager
area than hand-held massaging devices.
Physical therapy Intended to be filled with liquid paraffin wax Class B
40
paraffin wax bath for physical therapy.
Physical therapy Intended to apply hot steam as a physical Class B
41
steam bath therapy to a patient.
Intended to regenerate damaged cartilage,
Pulsed signal particularly by stimulating the production of Class C
42
therapy system collagen types that are present in healthy
cartilage.
Intended to provide a therapeutic deep
heat within specific volumes of the body
Short-wave
through the transcutaneous transmission of Class C
43 diathermy treatment
electromagnetic (EM) energy in the radio-
system
frequency (RF) bands of 13 MHz to 27.12
MHz
Intended to facilitate in-place walking,
jogging, or running to promote muscle
Standard treadmill, Class A
44 redevelopment, to restore motion to joints,
mechanical
and to promote weight loss and
cardiovascular fitness.
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Electrically powered unit intended to
facilitate in-place walking, jogging, or
Standard treadmill, Class A
45 running to promote muscle redevelopment,
powered
to restore motion to joints, and to promote
weight loss and cardiovascular fitness.
It is a Battery powered portable device
Intended to measure several or all
respiratory-gas volume and flow
parameters needed to evaluate basic
Telemetric pulmonary function [e.g., vital capacity
Class B
46 diagnostic (VC), peak expiratory flow (PEF), forced
spirometer expiratory volume (FEV), and forced
expiratory flow (FEF)], and to transmit the
pulmonary function data via a
communication device to a healthcare
professional(s) at a remote server.
Intended to influence cellular metabolism
using nuclear magnetic resonance (NMR)
for the treatment of degenerate and
Therapeutic nuclear pathological changes to the
Class C
47 magnetic movement/support profiles of a patient's
resonance system body, in particular diseased skeletal joints,
bones, and surrounding muscle tissue
(e.g., cervical and lumbar spine, shoulders,
elbows, hands, hips, knees, feet).
A device that is permanently fixed to the
wall intended for training and rehabilitation
Class A
48 Wall bars to regain and/or improve body movement
and balance and/or for strengthening the
limbs and the trunk of the body.
A silicone prosthetic ear which adheres to
the skin using safe, biocompatible glue is a
reconstructive option for patients born
Silicone Prosthetic with microtia and other birth differences
49 Class A
Ear such as Treacher Collins or Goldenhar
syndrome; as well as those who have
suffered traumatic injury or undergone
cancer resection surgery.
Silicone prosthetic nose is used to restore
normal contour and improve function for
Silicone Prosthetic patients who have experienced partial or
Class A
50 Nose total loss of their nose to traumatic injury,
disease or due to surgical removal of the
nose (rhinectomy).
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An external assembled lower limb
prosthesis is a device that is intended for
medical purposes and is a preassembled
External asembled
external artificial limb for the lower
51 lower limb Class A
extremity. Examples of external assembled
prosthesis
lower limb prostheses are the following:
Knee/shank/ankle/foot assembly and
thigh/knee/shank/ankle/foot assembly.
The prosthetic liner acts as an interface
that goes between a person's skin and his
External limb or her prosthetic. In short, it's a barrier –
52 prosthesis socket one that is applied to the skin before the Class A
liner prosthesis to protect the wearer's skin
while enhancing comfort and maintaining a
more consistent fit.
An artificial substitute for a missing finger
Finger/thumb
or thumb. Class A
53 prosthesis
A upper extremity prosthesis including a
simultaneously powered elbow and/or
shoulder with greater than two
simultaneous powered degrees of freedom
and controlled by non-implanted electrical
Upper extremity
components, is a prescription device
prosthesis including
intended for medical purposes, and is
a simultaneously
intended to replace a partially or fully
powered elbow
amputated or congenitally absent upper
and/or shoulder
extremity. It uses electronic inputs (other
with greater than
54 than simple, manually controlled electrical Class B
two simultaneous
components such as switches) to provide
powered degrees of
greater than two independent and
freedom and
simultaneously powered degrees of
controlled by non-
freedom and includes a simultaneously
implanted electrical
powered elbow and/or shoulder. Prosthetic
components.
arm components that are intended to be
used as a system with other arm
components must include all degrees of
freedom of the total upper extremity
prosthesis system.
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A powered lower extremity exoskeleton is
Powered lower a prescription device that is composed of
extremity an external, powered, motorized orthosis Class B
55
exoskeleton that is placed over a person's paralyzed or
weakened limbs for medical purposes.
A truncal orthosis is a device intended for
medical purposes to support or to
immobilize fractures, strains, or sprains of
the neck or trunk of the body. Examples of
Truncal Orthosis truncal orthoses are the following: Class A
56
Abdominal, cervical, cervical-thoracic,
lumbar, lumbo-sacral, rib fracture,
sacroiliac, and thoracic orthoses and
clavicle splints.
External prosthesis for upper limb distal to
shoulder joint. The device is intended to be
used by patients with upper limb loss or
Prosthesis External
57 deficiency. Prosthesis may include limb Class A
Arm
components, socket, frame, covering and
accessories to enable functional use of the
device.
A congenital hip dislocation abduction
Congenital hip splint is a device intended for medical
58 dislocation purposes to stabilize the hips of a young Class A
abduction splint child with dislocated hips in an abducted
position (away from the midline).
A Denis Brown splint is a device intended
for medical purposes to immobilize the
59 Denis Brown splint foot. It is used on young children with tibial Class A
torsion (excessive rotation of the lower leg)
or club foot.
An arm sling is a device intended for
medical purposes to immobilize the arm,
60 Arm sling Class A
by means of a fabric band suspended from
around the neck.
Crutches helps to transfer load from the
legs to the upper body. This is useful for
61 Crutches people who cannot use their legs to fully Class A
support the weight of their body, due to
temporary or permanent disabilities.
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The Power Knee is a motor-powered
microprocessor knee. It provides active
assistance while walking on level-ground,
climbing and descending ramps or stairs
62 Power Knee Class B
and when standing up. Power Knee
enables amputees to maintain and regain
mobility and participate in the daily
activities.
It holds abdominal muscles together to
relieve pain. Increase circulation at your
63 Abdominal Support surgical site to promote healing and Class A
decrease swelling. Make physical activity
more comfortable.
Myoelectric The complete control system is to be used
forequarter- exclusively for external prosthetic fitting of
64 Class A
amputation the upper limbs.
prosthesis
Limb support shaped as a stocking unit
that is worn on the upper or lower extremity
Stocking, medical
65 to support, correct, prevent deformity, or to Class A
support
align body structures for functional
improvement.
A back brace prevents unnecessary
movements that further damage the back.
66 Back Support/Brace This helps align your spine and strengthen Class A
your back muscles. Patients back can heal
and back pain will decrease.
A prosthetic and orthotic accessory is a
device intended for medical purposes to
support, protect, or aid in the use of a cast,
orthosis (brace), or prosthesis. Examples
Prosthetic and of prosthetic and orthotic accessories
67 Class A
orthotic accessory include the following: A pelvic support band
and belt, a cast shoe, a cast bandage, a
limb cover, a prosthesis alignment device,
a postsurgical pylon, a transverse rotator,
and a temporary training splint.
An external limb orthotic component is a
External limb device intended for medical purposes for Class A
68 orthotic component use in conjunction with an orthosis (brace)
to increase the function of the orthosis for a
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patient's particular needs. Examples of
external limb orthotic components include
the following: A brace-setting twister and
an external brace stirrup.
An external limb prosthetic component is a
device intended for medical purposes that,
when put together with other appropriate
components, constitutes a total prosthesis.
External limb Examples of external limb prosthetic
prosthetic components include the following: Ankle, Class A
69
component foot, hip, knee, and socket components;
mechanical or powered hand, hook, wrist
unit, elbow joint, and shoulder joint
components; and cable and prosthesis
suction valves.
Prosthesis, A controller for prosthetic terminal devices
external, arm, that enables grip and mode switching using
70 component, hand, passive RFID tags. Class A
external powered,
myopotential
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