The following data is part of a De Novo classification by Bio-medical Research Ltd. with the FDA for Innovo.
| DeNovo ID | DEN170049 |
| Device Name: | Innovo |
| Classification | Cutaneous Electrode Stimulator For Urinary Incontinence |
| Applicant | Bio-Medical Research Ltd. parkmore Business Park West Galway, IE H91nht7 |
| Contact | Anne-marie Keenan |
| Product Code | QAJ |
| CFR Regulation Number | 876.5330 [🔎] |
| Decision | Granted (DENG) |
| 501(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 | 2017-09-18 |
| Decision Date | 2018-11-06 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391533470494 | DEN170049 | 000 |
| 15391533470487 | DEN170049 | 000 |
| 15391533470470 | DEN170049 | 000 |
| 15391533470463 | DEN170049 | 000 |
| 15391533470456 | DEN170049 | 000 |
| 15391533470449 | DEN170049 | 000 |
| 15391533470432 | DEN170049 | 000 |
| 15391533470425 | DEN170049 | 000 |
| 15391533470418 | DEN170049 | 000 |