Clearance Summary
ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE received FDA 510(k) clearance under submission number K970131, sponsored by C.L. Mcintosh & Assoc., 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 1997-06-16.
- Submission: K970131
- Applicant / Sponsor: C.L. Mcintosh & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 1997-06-16
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.