QRC — Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation Class II
FDA product code QRC covers "Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation", a Class II medical device regulated under 21 CFR 876.5026. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QRC
- Device Class
- Class II
- Regulation Number
- 876.5026
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.