QWW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5021
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Eroxon (DEN220078) | Futura Medical Developments Limited | 2023-06-09 |
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