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510(k) Data Aggregation

    K Number
    K122076
    Device Name
    PERSONAL HEALTH CENTER (PHC)
    Date Cleared
    2013-04-15

    (273 days)

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

    ADFLOW HEALTH NETWORKS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ADFLOW Personal Health Center (PHC) is indicated for and consists of - 1) A Blood Pressure Monitor (BPM) that is used for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides blood pressure and heart rate data to the users, who are advised to consult a physician. - 2) a Body Composition Monitor (BCM) that is used as a body fat analyzer that estimates the percent body fat (%BF), percent lean body mass (%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis). The PHC is intended for healthy subjects between 8 and 92 years.
    Device Description
    The ADFLOW Personal Health Center (PHC) consists of a Blood Pressure Monitor (BPM) and a Body Composition Monitor (BCM). The BPM measures blood pressure and heart rate. The BCM estimates percent body fat, percent lean body mass, and percent total body water using bioelectrical impedance analysis (BIA).
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