Stimulator, Spinal-Cord, Totally Implanted for Relief of Pain Due to Diabetic Neuropathy
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Shanghai. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Jiangyin Sinbon Electronics Co Ltd Jiangsu, contract manufacturer
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
What Is It?
To relieve pain in patients with diabetic neuropathy
How Is QRB Classified?
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy is FDA product code QRB, 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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