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Wheelchair, Powered

FDA product code ITI · 575 cleared devices

Class 2 Physical Medicine
Regulation
21 CFR 890.3860
Review panel
PM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1978-05-12 – 2026-09-23

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

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