The following data is part of a De Novo classification by Ergon Medical Ltd. with the FDA for Prolong.
| DeNovo ID | DEN130047 |
| Device Name: | PROLONG |
| Classification | Vibrator For Climax Control Of Premature Ejaculation |
| Applicant | ERGON MEDICAL LTD. 25 Barker Close fishbourne, Chichester West Sussex, GB Po18 8bj |
| Contact | Barry Pearce |
| Product Code | PIA |
| CFR Regulation Number | 876.5025 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2013-11-18 |
| Decision Date | 2015-03-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |