Clearance Summary
MANUAL MASSAGE ROLLER received FDA 510(k) clearance under submission number K936312, sponsored by Mckenna & Cuneo. 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 1996-01-29.
- Submission: K936312
- Applicant / Sponsor: Mckenna & Cuneo
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1996-01-29
Classification & Regulation
This clearance is catalogued under FDA product code LYG and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.