Stimulator, Tibial, Electrical, Implantable, for Urinary Incontinence
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Shanghai. 1 is a contract manufacturer.
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
What Is This Device?
Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve.
How Is QPT Classified?
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence is FDA product code QPT, 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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