K223595 is an FDA 510(k) clearance 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 , Ltd. (Hod-Hasharon, IL). The FDA issued a Cleared decision on May 1, 2023, 150 days after receiving the submission on December 2, 2022.
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 | K223595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2022 |
| Decision Date | May 01, 2023 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |