Support, Head and Trunk, Wheelchair

How Is IMS Classified?

Support, Head And Trunk, Wheelchair is FDA product code IMS, Class 1, 21 CFR 890.3910.

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

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2008. None was by a company in China. The root cause the FDA records most often is Process control (1).

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