Stimulator, Nerve, Transcutaneous, for Pain Relief

How Is GZJ Classified?

Stimulator, Nerve, Transcutaneous, For Pain Relief is FDA product code GZJ, Class 2, 21 CFR 882.5890.

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 17 clearances under this code; the FDA took a median of 161 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 3 were reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Material/Component Contamination (1) and PMA (1).

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