K214037
- 510(k) number
- K214037
- Device name
- Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
- Applicant
- Ergo-Flex Technologies, LLC TX · US
- Product code
- ITH — Equipment, Traction, Powered
- Decision date
- 2024-02-22
- Date received
- 2021-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K214037.pdf
Official FDA record: K214037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.