510(k) K214037 ยท ITH Equipment, Traction, Powered
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
| Applicant | Ergo-Flex Technologies, LLC, Conroe TX, US |
| Decision | Substantially Equivalent, Feb 22, 2024 |
| Received | Dec 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214037
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.