Stimulator, Neuromuscular, External Functional

What Is FDA Product Code GZI?

Stimulator, Neuromuscular, External Functional is FDA product code GZI, Class 2, 21 CFR 882.5810.

How Does It Reach the US Market?

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 3 clearances under this code; the FDA took a median of 427 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Device Design (1) and Nonconforming Material/Component (1).

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