Clearance Summary
LO-BAK TRAX received FDA 510(k) clearance under submission number K110858, sponsored by Roland F Berthiaume, DC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-08-02.
- Submission: K110858
- Applicant / Sponsor: Roland F Berthiaume, DC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5850
- Decision date: 2011-08-02
Classification & Regulation
This clearance is catalogued under FDA product code HST and 21 CFR 888.5850, within the Orthopedic review panel as a Class I device.