-
New Search
Back to Search Results
Device
percutaneous nerve stimulator for opioid withdrawal
Regulation Description
Percutaneous nerve stimulator for substance use disorders.
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
Office of Neurological and Physical Medicine Devices
(OHT5)
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
ReportingIneligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Third Party Review
Not Third Party Eligible
-