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510(k) Data Aggregation

    K Number
    K173093
    Device Name
    TAMA BEMS device
    Date Cleared
    2018-06-05

    (249 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAMA Research Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes
    Device Description
    The TAMA BEMS Device is a microcurrent stimulator producing electrical currents up to 800 microamps. It is intended for aesthetic purposes. It has built-in pushbuttons to allow the user to adjust the output current from 0 to 800 micro-amps, as well as changing the modality (output frequency). The BEMS device is a battery-operated device that uses a rechargeable battery. When the device is plugged into the AC outlet for charging, it becomes disabled and no treatments can be performed. The BEMS device also has LED indicators to show output intensity, battery level, and output mode. A Flow light shows when probes contact the skin, and current is flowing through the patient. If the measured current through the probes does not match the set point selected by the user, the Flow LED turns off to indicate insufficient current flow.
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