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Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

FDA product code QRC · 3 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5026
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-05-01 – 2026-04-06

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.

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