Clearance Summary
HERO 1, MODEL LY-ESB220 received FDA 510(k) clearance under submission number K031621, sponsored by Comfort Orthopedic 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 2004-01-22.
- Submission: K031621
- Applicant / Sponsor: Comfort Orthopedic Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3900
- Decision date: 2004-01-22
Classification & Regulation
This clearance is catalogued under FDA product code IPL and 21 CFR 890.3900, within the Physical Medicine review panel as a Class II device.