Binder, Medical, Therapeutic

How Is MDR Classified?

Binder, Medical, Therapeutic is FDA product code MDR, Class 1, 21 CFR 880.5160.

How Does It Reach the US Market?

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 19 recalls under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Process control (19).

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