Wheelchair, Powered

What Is This Device?

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).

What Is FDA Product Code ITI?

Wheelchair, Powered is FDA product code ITI, Class 2, 21 CFR 890.3860.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 113 clearances under this code; the FDA took a median of 118 days from receipt to decision on them.

5 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 71 recalls under this product code since 2003. None was by a company in China. 7 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (13), Software design (8) and Component design/selection (4). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.