Clearance Summary
THERAPEUTIC MASSAGE COMPANION received FDA 510(k) clearance under submission number K060846, sponsored by Endurance Therapeutics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-12-03.
- Submission: K060846
- Applicant / Sponsor: Endurance Therapeutics
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2007-12-03
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.