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Wheelchair, Stair Climbing

FDA product code IMK · 3 cleared devices

Class 2 Physical Medicine
Regulation
21 CFR 890.3890
Review panel
PM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-03-02 – 2025-01-30

A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. 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.

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