In2
in2Record
1manufacturer
2catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Fujian. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Something High Electric (Xiamen) Company Inc. | Xiamen | Fujian | Contract manufacturer | 2 |
Record
| Listed by | Virility Medical Ltd., Israel |
|---|---|
| FDA product code | QRC |
| Device type | Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5026 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K223595 |
| Record published | 2024-11-18 |
| Record revised | 2025-06-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| VP42-Hi | 2 | In distribution | |
| VP41-Hi | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252809 | 2026-04-06 |
| K223595 | 2023-05-01 |
| DEN210012 | 2021-11-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.