Device |
percutaneous nerve stimulator for opioid withdrawal |
Definition |
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders. |
Physical State |
A signal generator connected to percutaneous electrodes. |
Technical Method |
Electrical stimulation of nerve branches using percutaneous electrodes. |
Target Area |
Cranial and occipital nerve branches. |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | PZR |
Premarket Review |
Neuromodulation and Physical Medicine Devices
(DHT5B)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
510(k)
|
Regulation Number |
882.5896
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |