Stimulator, Electrical, Implanted, for Essential Tremor
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Shanghai.
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
What Is It?
Deep Brain Stimulation for the treatment of essential tremor
What Is FDA Product Code PJS?
Stimulator, Electrical, Implanted, For Essential Tremor is FDA product code PJS, Class 3.
What Does It Take to Sell It in the United States?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
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