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    K Number
    K100862
    Device Name
    BODYFLOW P2CH
    Manufacturer
    PHYSIOMED ELEKTROMEDIZIN AG
    Date Cleared
    2011-04-21

    (388 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHYSIOMED ELEKTROMEDIZIN AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bodyflow -P2CH is a powered muscle stimulator intended for - Increased local blood circulation - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    Device Description
    The Bodyflow®-P2CH is a device which delivers muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by permanently installed, rechargeable batteries.
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