Clearance Summary
MOTOR MASSAGE PILLOW received FDA 510(k) clearance under submission number K912479, sponsored by Supreme Import , Ltd.. 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 1991-08-09.
- Submission: K912479
- Applicant / Sponsor: Supreme Import , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5975
- Decision date: 1991-08-09
Classification & Regulation
This clearance is catalogued under FDA product code IRO and 21 CFR 890.5975, within the Physical Medicine review panel as a Class I device.