QRC
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5026
- Medical specialty
- Gastroenterology, Urology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| in2 Smart (in2S) (K252809) | Virility Medical , Ltd. | 2026-04-06 |
| MOR (K241897) | Morari, Inc. | 2025-02-11 |
| vPATCH (K223595) | Virility Medical , Ltd. | 2023-05-01 |
| vPatch (DEN210012) | Virility Medical | 2021-11-23 |
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Every clearance here is in the API, with alerts when new ones post.