Stimulator, Nerve, Battery-Powered

What Is FDA Product Code BXN?

Stimulator, Nerve, Battery-Powered is FDA product code BXN, Class 2, 21 CFR 868.2775.

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

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 2 clearances under this code; the FDA took a median of 247 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.

What Has Gone Wrong With It?

The FDA has recorded 5 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Component design/selection (4) and Process control (1).

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