Clearance Summary
BACK-ON-TRAC, MODEL 101BOT received FDA 510(k) clearance under submission number K984190, sponsored by Back-On-Track, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1999-03-15.
- Submission: K984190
- Applicant / Sponsor: Back-On-Track, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5850
- Decision date: 1999-03-15
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.