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U.S. Department of Health and Human Services

Product Classification
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Device non-implanted electrical stimulation device for management of premature ejaculation
Regulation Description Non-implanted electrical stimulation device for management of premature ejaculation.
Definition A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.
Physical State Electrode(s) designed to stimulate perineal muscles and nerves.
Technical Method Electrical stimulation of perineal muscles and nerves.
Target Area Perineal muscles and nerves.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQRC
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.5026
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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