Massager, Vacuum, Radio Frequency Induced Heat

What Is This Device?

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

How Is PBX Classified?

Massager, Vacuum, Radio Frequency Induced Heat is FDA product code PBX, Class 2, 21 CFR 878.4400.

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 1 clearance under this code; the FDA took 140 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2017. None was by a company in China. The root cause the FDA records most often is Software design (1).

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