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510(k) Data Aggregation

    K Number
    K143108
    Device Name
    HealthGuard-15
    Manufacturer
    FUTREX, INC.
    Date Cleared
    2015-03-27

    (149 days)

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

    FUTREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HealthGuard-15 is a non-invasive screening device intended for use in corporate wellness facilities and in health/fitness clubs. It is not for use in medical facilities such as hospitals or doctor's offices. This device measures systolic and diastolic blood pressure, heart rate, percent body fat and weight. It is operated by the client supplied PC computer. The device is intended for users eighteen years and older.
    Device Description
    The HealthGuard-15 is a portable health kiosk that provides a means for measuring and tracking an individual's systolic and diastolic blood pressure, heart rate, percent body fat and weight. The HG-15 integrates two FDA market cleared devices ---- the Omron HEM-7200-Z [BP742] (K121932) for measurement of blood pressure and heart rate, and the FUTREX-6100/XL (K963271) for the estimation of the percent body fat --into a health kiosk with similar performance as the Health Check Kiosk (K063008). The HG-15 kiosk can typically be installed in corporate offices, lunch rooms or other community places so that employees can be measured as part of a corporate wellness program to track changes over time. It is not for use in hospitals or in other health care facilities. The HG-15 is delivered without the necessary PC computer. The client supplies the computer and Futrex supplies not only the HealthGuard-15 "kiosk" but also supplies the software that will be driven by the client's computer. In addition to making the measurements, the HealthGuard-15 also provides the recognized norms for systolic and diastolic blood pressure and weight. It provides a direct comparison of the user's measurements to these established norms, thereby providing education and motivation to the user. The computer/s monitor also warns the user not to start any exercise or diet program without first discussing it with their healthcare professional.
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    K Number
    K963271
    Device Name
    FUTREX-6100/XL
    Manufacturer
    FUTREX, INC.
    Date Cleared
    1998-08-19

    (729 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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