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U.S. Department of Health and Human Services

Product Classification
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Device temporarily implanted peripheral nerve stimulation system for sustained pain relief
Regulation Description Implanted peripheral nerve stimulator for pain relief.
Definition A temporarily implanted peripheral nerve stimulation system for sustained pain relief is a prescription device that uses an external electrical stimulator(s) and percutaneous electrode(s) to stimulate a peripheral nerve(s) to provide sustained pain relief after the end of treatment.
Physical State External electrical stimulator(s) with percutaneous electrode(s)
Technical Method Applies electrical current through percutaneous electrode(s)
Target Area Peripheral nerves excluding cranial and facial nerves
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeSCN
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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