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510(k) Data Aggregation

    K Number
    K073227
    Device Name
    SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
    Manufacturer
    AIIA COMMUNICATION INC.
    Date Cleared
    2008-03-20

    (126 days)

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

    AIIA COMMUNICATION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Measurement in healthy subjects of: Estimated : ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass; Actual: Weight, BMI, Impedance Values
    Device Description
    SLIMMANAGER is a body composition analyzer and uses Bioelectrical Impedance Analysis technology to determine body composition parameters. Using a principle that an electric current has a low impedance when it flows in muscle or cellular fluids containing lots of water while it has a high impedance such as in fat and bone tissues slowing and stopping an applied current, BIA sends an extremely weak electric current through the body and detects the relative response after it flows our body's various substances, and then it can determines lean tissue, fat, water mass. All measurements made by SLIMMANAGER can be recorded & saved in the website real-time by the Internet transmission as well in the device, and in his own page people could check their changing progress even a minute change without an expert's advice at anywhere, at anytime. N-40 is designed by Linux system with touch monitor, while SM-300 should be interfaced with customer's PC.
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    K Number
    K051589
    Device Name
    SLIMMANAGER, MODEL SM-X, SM-E
    Manufacturer
    AIIA COMMUNICATION INC.
    Date Cleared
    2005-10-31

    (138 days)

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

    AIIA COMMUNICATION INC.

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

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