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U.S. Department of Health and Human Services

Product Classification

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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 CodePZR
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible