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Wheelchair, Mechanical

FDA product code IOR · 458 cleared devices

Class 1 Physical Medicine
Regulation
21 CFR 890.3850
Review panel
PM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1978-02-13 – 2026-09-22

A mechanical wheelchair is a manually 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/or require an assistive device for mobility.

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