The following data is part of a premarket notification filed by Niveus Medical, Inc. with the FDA for Muscle Stimulation System 110.
| Device ID | K150742 |
| 510k Number | K150742 |
| Device Name: | Muscle Stimulation System 110 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | NIVEUS MEDICAL, INC. 849 Independence Avenue Suite C Mountain View, CA 94043 |
| Contact | Brian Fahey |
| Correspondent | Cindy Domecus DOMECUS CONSULTING SERVICES LLC 1171 BARROILHET DRIVE Hillsbrough, CA 94010 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-23 |
| Decision Date | 2015-07-23 |
| Summary: | summary |