Wheelchair, Mechanical

What Is It?

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.

How Is IOR Classified?

Wheelchair, Mechanical is FDA product code IOR, Class 1, 21 CFR 890.3850.

What Does It Take to Sell It in the United States?

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 44 clearances under this code; the FDA took a median of 84 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 3 were reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 40 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Component design/selection (12), Device Design (8) and Employee error (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.