Transcranial Magnetic Stimulator

What Is This Device?

A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.

What Is FDA Product Code OBP?

Transcranial Magnetic Stimulator is FDA product code OBP, Class 2, 21 CFR 882.5805.

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 Has Gone Wrong With It?

The FDA has recorded 5 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (3), Employee error (1) and Process control (1).

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