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U.S. Department of Health and Human Services

Product Classification
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Device cutaneous electrode stimulator for urinary incontinence
Regulation Description Transcutaneous electrical continence device.
Definition A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Physical State Electrodes
Technical Method Current applied to pelvic floor muscles to improve strength.
Target Area Pelvic floor muscles
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQAJ
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.5330
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
Third Party Review Not Third Party Eligible
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