The following data is part of a De Novo classification by Innovative Health Solutions (ihs), Inc. with the FDA for Ib-stim.
| DeNovo ID | DEN180057 |
| Device Name: | IB-Stim |
| Classification | Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs) |
| Applicant | Innovative Health Solutions (IHS), Inc. 829 South Adams St. Versailles, IN 47042 |
| Contact | Tom Carrico |
| Product Code | QHH |
| CFR Regulation Number | 876.5340 [🔎] |
| 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 | Neurology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2018-10-25 |
| Decision Date | 2019-06-07 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |