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U.S. Department of Health and Human Services

Product Classification

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Device non-implanted nerve stimulator for pain associated with irritable bowel syndrome (ibs)
Definition A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.
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 Gastroenterology/Urology
Review Panel Neurology
Product CodeQHH
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 876.5340
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
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