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510(k) Data Aggregation

    K Number
    K023478
    Device Name
    INBODY AP1 BODY COMPOSITION ANALYZER
    Manufacturer
    BIOSPACE CO.,LTD
    Date Cleared
    2003-05-13

    (209 days)

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

    BIOSPACE CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Measurement Of: Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Actual : Weight, Body Mass Index (BMI),and Impedance Values
    Device Description
    InBody AP1 is an impedance plethysmograph body composition analyzer. The device determines body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components.
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