Deep Brain Stimulation for the Treatment of Dystonia
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 This Device?
To stimulate deep brain structure to manage dystonia symptoms
How Is SGS Classified?
Deep Brain Stimulation For The Treatment Of Dystonia is FDA product code SGS, 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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