Clearance Summary
ULTRA (THERAPEUTIC ULTRASOUND DEVICE) received FDA 510(k) clearance under submission number K895690, sponsored by Excel Tech. , Ltd.. 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 1990-02-20.
- Submission: K895690
- Applicant / Sponsor: Excel Tech. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5860
- Decision date: 1990-02-20
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.