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FDA 510(k)

WS(TM) Far-Infrared Therapy Unit, Model KP-B210

K-Number: K160849 · 2016-12-15

ApplicantWs Far IR Medical Technology Co., Ltd.
Decision Date2016-12-15
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WS(TM) Far-Infrared Therapy Unit, Model KP-B210 is a medical device manufactured by Ws Far IR Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-12-15 under approval number K160849. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WS(TM) Far-Infrared Therapy Unit, Model KP-B210?

WS(TM) Far-Infrared Therapy Unit, Model KP-B210 is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Ws Far IR Medical Technology Co., Ltd.. The 510(k) number is K160849.

When was WS(TM) Far-Infrared Therapy Unit, Model KP-B210 approved by the FDA?

WS(TM) Far-Infrared Therapy Unit, Model KP-B210 received FDA 510(k) clearance on 2016-12-15, under approval number K160849.

What company makes WS(TM) Far-Infrared Therapy Unit, Model KP-B210?

WS(TM) Far-Infrared Therapy Unit, Model KP-B210 is manufactured by Ws Far IR Medical Technology Co., Ltd..

What is the FDA product code for WS(TM) Far-Infrared Therapy Unit, Model KP-B210?

The FDA product code for WS(TM) Far-Infrared Therapy Unit, Model KP-B210 is ILY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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