Clearance Summary
SUN-RAIN ULTRASONIC THERAPY, SU-100 received FDA 510(k) clearance under submission number K024013, sponsored by Sun-Rain System 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 2003-10-31.
- Submission: K024013
- Applicant / Sponsor: Sun-Rain System Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 2003-10-31
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.