IOR

Wheelchair, Mechanical

Product code

IOR

Device name

Wheelchair, Mechanical

Device class

Class 1

21 CFR

21 CFR 890.3850

Medical specialty

Physical Medicine

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

463

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (26)

Last three years. Most recent: 2026-08-06.

19 summaries are archived here for direct download.