Wheelchair, Standup

What Is FDA Product Code IPL?

Wheelchair, Standup is FDA product code IPL, Class 2, 21 CFR 890.3900.

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 1 clearance under this code; the FDA took 93 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 0013. None was by a company in China. The root cause the FDA records most often is Component design/selection (1).

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