Dermal Cooling Pack/Vacuum/Massager

What Is It?

The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

How Is OOK Classified?

Dermal Cooling Pack/Vacuum/Massager is FDA product code OOK, Class 2, 21 CFR 878.4340.

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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 6 recalls under this product code since 2021. 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.