Assembly, Knee/Shank/Ankle/Foot, External

How Is ISW Classified?

Assembly, Knee/Shank/Ankle/Foot, External is FDA product code ISW, Class 2, 21 CFR 890.3500.

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.

What Has Gone Wrong With It?

The FDA has recorded 10 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Software design (4), Device Design (2) and Process control (2).

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