Clearance Summary
CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE received FDA 510(k) clearance under submission number K844025, sponsored by Craftmatic/Contour Organization, Inc.. 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 1985-01-17.
- Submission: K844025
- Applicant / Sponsor: Craftmatic/Contour Organization, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3110
- Decision date: 1985-01-17
Classification & Regulation
This clearance is catalogued under FDA product code INO and 21 CFR 890.3110, within the Physical Medicine review panel as a Class II device.