Clearance Summary
WS(TM) Far-Infrared Therapy Unit, Model KP-B210 received FDA 510(k) clearance under submission number K160849, sponsored by Ws Far IR Medical Technology 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 2016-12-15.
- Submission: K160849
- Applicant / Sponsor: Ws Far IR Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2016-12-15
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.