Stimulator, Transcutaneous Electrical, Aesthetic Purposes

What Is FDA Product Code NFO?

Stimulator, Transcutaneous Electrical, Aesthetic Purposes is FDA product code NFO, 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 16 clearances under this code; the FDA took a median of 180 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2012. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (2).

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