PIA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Vibrator For Climax Control Of Premature Ejaculation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5025
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Vibrator for climax control training for the treatment of premature ejaculation.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| PROLONG (DEN130047) | Ergon Medical , Ltd. | 2015-03-20 |
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Every clearance here is in the API, with alerts when new ones post.