The following data is part of a premarket notification filed by Bioness Inc. with the FDA for Stimrouter Neuromodulation System.
| Device ID | K211965 |
| 510k Number | K211965 |
| Device Name: | StimRouter Neuromodulation System |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355 |
| Contact | Sageev George |
| Correspondent | Sageev George Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-24 |
| Decision Date | 2022-02-23 |