BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES

    K Number: K080465 · Decision Jul 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    148

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    Basic Information

    Device Name
    WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES
    K Number
    K080465
    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
    February 21, 2008
    Decision Date
    July 18, 2008
    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
    K160849 WS(TM) Far-Infrared Therapy Unit, Model KP-B210