Clearance Summary
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac received FDA 510(k) clearance under submission number K214037, sponsored by Ergo-Flex Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2024-02-22.
- Submission: K214037
- Applicant / Sponsor: Ergo-Flex Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5900
- Decision date: 2024-02-22
Classification & Regulation
This clearance is catalogued under FDA product code ITH and 21 CFR 890.5900, within the Physical Medicine review panel as a Class II device.