The following data is part of a premarket notification filed by Niveus Medical, Inc. with the FDA for Muscle Stimulation System.
| Device ID | K123642 |
| 510k Number | K123642 |
| Device Name: | MUSCLE STIMULATION SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | NIVEUS MEDICAL, INC. 1171 BARROILHET DRIVE Hillsborough, CA 94010 |
| Contact | Cindy Domecus, R.a.c. (us & Eu) |
| Correspondent | Cindy Domecus, R.a.c. (us & Eu) NIVEUS MEDICAL, INC. 1171 BARROILHET DRIVE Hillsborough, CA 94010 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-26 |
| Decision Date | 2013-03-29 |
| Summary: | summary |