Clearance Summary
MGI STRENGTH/FITNESS SYS-MODEL #PU-101 received FDA 510(k) clearance under submission number K832528, sponsored by Mgi Strength/Fitness Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1983-10-20.
- Submission: K832528
- Applicant / Sponsor: Mgi Strength/Fitness Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2780
- Decision date: 1983-10-20
Classification & Regulation
This clearance is catalogued under FDA product code JOM and 21 CFR 870.2780, within the Cardiovascular review panel as a Class II device.