The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik Gmbh with the FDA for Bodyfix.
| Device ID | K013391 |
| 510k Number | K013391 |
| Device Name: | BODYFIX |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH FEYERABENDSTRASSE 13-15 Schwabmunchen, DE 86830 |
| Contact | Christian Muller |
| Correspondent | Christian Muller MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH FEYERABENDSTRASSE 13-15 Schwabmunchen, DE 86830 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2002-01-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BODYFIX 77613537 3638909 Dead/Cancelled |
726929 Ontario Ltd. 2008-11-13 |
![]() BODYFIX 73574874 1405063 Dead/Cancelled |
KELLWOOD COMPANY 1985-12-23 |