Clearance Summary
ISOROBIC SKINFOLD CALIPER received FDA 510(k) clearance under submission number K810116, sponsored by Fitness Motivation Institute of America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1981-02-04.
- Submission: K810116
- Applicant / Sponsor: Fitness Motivation Institute of America
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4150
- Decision date: 1981-02-04
Classification & Regulation
This clearance is catalogued under FDA product code KTZ and 21 CFR 888.4150, within the Orthopedic review panel as a Class I device.