Clearance Summary
FIGURETRIM received FDA 510(k) clearance under submission number K780730, sponsored by Jay-Mar INternational Enterprises, IN. 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 1978-05-09.
- Submission: K780730
- Applicant / Sponsor: Jay-Mar INternational Enterprises, IN
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1850
- Decision date: 1978-05-09
Classification & Regulation
This clearance is catalogued under FDA product code ISB and 21 CFR 890.1850, within the Physical Medicine review panel as a Class II device.