Transcranial Magnetic Stimulation System for Obsessive-Compulsive Disorder

What Is This Device?

External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).

What Is FDA Product Code QCI?

Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder is FDA product code QCI, Class 2, 21 CFR 882.5802.

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. 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.