IMK

Wheelchair, Stair Climbing

Product code

IMK

Device name

Wheelchair, Stair Climbing

Device class

Class 2

21 CFR

21 CFR 890.3890

Medical specialty

Physical Medicine

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

FDA classification definition

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.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-01-30.