DEN210012 is an FDA 510(k) submission for the vPatch. This device is classified as a Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation (Class II - Special Controls, product code QRC).
Submitted by Virility Medical (Hod-Hasharon, IL). The FDA issued a Not Cleared (DENG) decision on November 23, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5026. 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..
| 510(k) Number | DEN210012 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 30, 2021 |
| Decision Date | November 23, 2021 |
| Days to Decision | 238 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QRC - Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5026 |
| 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. |