ITI

Wheelchair, Powered

Product code

ITI

Device name

Wheelchair, Powered

Device class

Class 2

21 CFR

21 CFR 890.3860

Medical specialty

Physical Medicine

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

98

Summaries archived here

70 (direct download)

510(k) clearances (all years, FDA)

586 (all years; only the last 3 years are listed here)

FDA classification definition

A powered wheelchair is a battery-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 require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

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

510(k) clearances, last 3 years (98)

Last three years. Most recent: 2026-08-21.

70 summaries are archived here for direct download.