K214037 is an FDA 510(k) clearance for the Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac. This device is classified as a Equipment, Traction, Powered (Class II - Special Controls, product code ITH).
Submitted by Ergo-Flex Technologies, LLC (Conroe, US). The FDA issued a Cleared decision on February 22, 2024, 791 days after receiving the submission on December 23, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.
| 510(k) Number | K214037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2021 |
| Decision Date | February 22, 2024 |
| Days to Decision | 791 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ITH - Equipment, Traction, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5900 |