Clearance Summary
HES ULTRASONIC THERAPY APPLIANCE received FDA 510(k) clearance under submission number K040798, sponsored by Hwang Sun Enterprise Co., 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 2004-08-04.
- Submission: K040798
- Applicant / Sponsor: Hwang Sun Enterprise Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 2004-08-04
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.