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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, peripheral nerve, non-implanted, for urinary incontinence
Regulation Description Nonimplanted, peripheral electrical continence device.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNAM
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.5310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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