PIA — Vibrator For Climax Control Of Premature Ejaculation Class II
FDA product code PIA covers "Vibrator For Climax Control Of Premature Ejaculation", a Class II medical device regulated under 21 CFR 876.5025. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PIA
- Device Class
- Class II
- Regulation Number
- 876.5025
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Vibrator for climax control training for the treatment of premature ejaculation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN130047 | ergon medical | PROLONG | March 20, 2015 |