Clearance Summary
MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED received FDA 510(k) clearance under submission number K923797, 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 1992-11-06.
- Submission: K923797
- Applicant / Sponsor: Rich-Mar Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5860
- Decision date: 1992-11-06
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.