510(k) K160849
K160849 is an FDA 510(k) premarket notification submitted by Ws Far IR Medical Technology Co., Ltd. for the device "WS(TM) Far-Infrared Therapy Unit, Model KP-B210". The FDA issued a decision of Substantially Equivalent on December 15, 2016. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Ws Far IR Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2016
- Date Received
- March 28, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type