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    K Number
    K123921
    Device Name
    BODYTRONIC 200
    Manufacturer
    BAUERFEIND AG
    Date Cleared
    2013-04-26

    (127 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAUERFEIND AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BODYTRONIC 200 is a photoelectric plethysmograph intended for the measurement of the leg vein function.
    Device Description
    The BODYTRONIC 200 is based on light reflection rheography. A small quantity of infrared light is radiated into the legs just above the ankles, and the reflected light is measured. On the basis of the quantity of reflected light over a defined period, conclusions can be drawn about the flow of blood in the veins.
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    K Number
    K111662
    Device Name
    VENOTRAIN CURAFLOW
    Manufacturer
    BAUERFEIND AG
    Date Cleared
    2011-10-04

    (112 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAUERFEIND AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.
    Device Description
    The VenoTrain curaflow compression garments help to prevent pooling of blood and fluid in the extremities by applying controlled pressure. The VenoTrain garments are flat knit using yarns made of nylon and spandex and then sewn together.
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