Clearance Summary
ROTAGYM received FDA 510(k) clearance under submission number K832940, sponsored by I-Rep, 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 1983-11-07.
- Submission: K832940
- Applicant / Sponsor: I-Rep, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5360
- Decision date: 1983-11-07
Classification & Regulation
This clearance is catalogued under FDA product code ISD and 21 CFR 890.5360, within the Physical Medicine review panel as a Class II device.