External Upper Limb Tremor Stimulator

What Is It?

An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.

What Is FDA Product Code QBC?

External Upper Limb Tremor Stimulator is FDA product code QBC, Class 2, 21 CFR 882.5897.

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.