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510(k) Data Aggregation

    K Number
    K152107
    Device Name
    HealthChek Network Health Station
    Manufacturer
    HEALTHCHEK NETWORK, LLC
    Date Cleared
    2016-04-12

    (258 days)

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

    HEALTHCHEK NETWORK, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.
    Device Description
    The HealthChek Network Health Station, Model HCK - 2000 is a kiosk designed for use by the general adult public in public locations to measure the user's health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. The HealthChek Network Health Station kiosk is not a diagnostic device. It does not introduce any novel modes of operational theory.
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