Clearance Summary
RM VI-HV received FDA 510(k) clearance under submission number K771157, sponsored by Rich-Mar Corp.. 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 1977-07-21.
- Submission: K771157
- Applicant / Sponsor: Rich-Mar Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5860
- Decision date: 1977-07-21
Classification & Regulation
This clearance is catalogued under FDA product code IMG and 21 CFR 890.5860, within the Physical Medicine review panel as a Class II device.