Ingested, Transient, Space Occupying Device for Weight Management And/Or Weight Loss

What Is This Device?

This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

What Is FDA Product Code QFQ?

Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss is FDA product code QFQ, Class 2, 21 CFR 876.5982.

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.