The following data is part of a premarket notification filed by Bemer Int. Ag with the FDA for Bemer Classic Set, Bemer Pro-set.
| Device ID | K151834 |
| 510k Number | K151834 |
| Device Name: | BEMER Classic Set, BEMER Pro-Set |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | BEMER Int. AG Austrasse 15 Triesen, LI 9495 |
| Contact | Sven Bieler |
| Correspondent | Sven Bieler Biomaterialize P.O. BOX 50 Tecumseh, MI 49286 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2017-02-22 |
| Summary: | summary |