Device type

Wheelchair, Mechanical

Product code IOR · Class I · 21 CFR 890.3850 · Physical Medicine

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.

FDA classification database