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510(k) Data Aggregation

    K Number
    K160849
    Device Name
    WS(TM) Far-Infrared Therapy Unit, Model KP-B210
    Date Cleared
    2016-12-15

    (262 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    WS FAR IR MEDICAL TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WS(TM) Far-Infrared Therapy Unit, Model: KP-B210, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains.
    Device Description
    The WSTM Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 um Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
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    K Number
    K080465
    Device Name
    WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES
    Date Cleared
    2008-07-18

    (148 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    WS FAR IR MEDICAL TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WS™ THERAPY UNITS, TY-101N and TY-101F, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
    Device Description
    The WS™ THERAPY UNIT (Model # TY-101 series), is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3 ~ 25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net or the emitter to prevent fire or direct touch by the user. The entire unit is mounted on base that is easy to move. The device uses 110 Vac as power source. it meets the related requirement of IEC 60601-1 Electrical Safety.
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