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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

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

    K Number: K160849 · Decision Dec 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    262

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    Basic Information

    Device Name
    WS(TM) Far-Infrared Therapy Unit, Model KP-B210
    K Number
    K160849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ws Far IR Medical Technology Co., Ltd.
    Date Received
    March 28, 2016
    Decision Date
    December 15, 2016
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Ws Far IR Medical Technology Co., Ltd.

    K Number Device Name
    K080465 WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES