Stimulator, Electrical, Implanted, for Parkinsonian Tremor
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Shanghai.
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
What Is FDA Product Code MHY?
Stimulator, Electrical, Implanted, For Parkinsonian Tremor is FDA product code MHY, 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.
What Do the Recalls Say?
The FDA has recorded 46 recalls under this product code since 2005. None was by a company in China. 1 is Class I, the most serious grade.
The root causes the FDA records most often are Device Design (5), Software design (5) and Process design (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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