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FDA 510(k)

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

Número K: K160849 · 2016-12-15

RequerenteWs Far IR Medical Technology Co., Ltd.
Data da decisão2016-12-15
Código do produtoILY
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Ws Far IR Medical Technology Co., Ltd.. The 510(k) number is K160849.

When did WS(TM) Far-Infrared Therapy Unit, Model KP-B210 receive FDA 510(k) clearance?

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

Who is the listed applicant for WS(TM) Far-Infrared Therapy Unit, Model KP-B210?

The FDA 510(k) record lists Ws Far IR Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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