The following data is part of a premarket notification filed by Bemer Int. Ag with the FDA for Bemer Therapy Systems, Bemer Classic Set, Bemer Pro-set.
| Device ID | K210174 |
| 510k Number | K210174 |
| Device Name: | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Bemer INT. AG Austrasse 15 Triesen, LI 9495 |
| Contact | Sandra Schwarzenberger |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-01-22 |
| Decision Date | 2021-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640161461086 | K210174 | 000 |
| 07640161460218 | K210174 | 000 |