Clearance Summary
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES received FDA 510(k) clearance under submission number K982544, 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 1998-11-19.
- Submission: K982544
- Applicant / Sponsor: Rich-Mar Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 1998-11-19
Classification & Regulation
This clearance is catalogued under FDA product code IMI and 21 CFR 890.5300, within the Physical Medicine review panel as a Class II device.