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510(k) Data Aggregation

    K Number
    K140360
    Device Name
    HEALTH KIOSK
    Date Cleared
    2015-04-10

    (422 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENGAGEMENTHEALTH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EngagementHealth Kiosk is intended to be used by the general public as a non-invasive multi-functional unit which measures a person's weight, blood pressure and heart rate. The kiosk is not intended to be a diagnostic device and does not perform any diagnoses. Rather, the kiosk provides the user with weight and systolic/diastolic blood pressure to be used as supplemental data when consulting a professional physician. The EngagementHealth Kiosk is intended to be fully unattended and placed within public or corporate environments. The user can choose to send the data to the EngagementHealth web portal for later data visualization.
    Device Description
    The EngagementHealth Kiosk is a device which provides a method for identifying a person's systolic and diastolic blood pressure, pulse rate, weight and displays the results onto the touch screen LCD computer screen. The individual using the device is seated during the entire operation of the device for accurate blood pressure readings.
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