The following data is part of a premarket notification filed by Miha Bodytec Gmbh with the FDA for Miha Bodytec Ii.
| Device ID | K201975 |
| 510k Number | K201975 |
| Device Name: | Miha Bodytec II |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Miha Bodytec Gmbh Siemensstr. 1 Gersthofen, DE 86368 |
| Contact | Felix Schweigert |
| Correspondent | Felix Schweigert Miha Bodytec Gmbh Siemensstr. 1 Gersthofen, DE 86368 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-16 |
| Decision Date | 2021-03-11 |