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510(k) Data Aggregation

    K Number
    K082147
    Device Name
    BODYMETRIX BX2000
    Manufacturer
    INTELAMETRIX, INC
    Date Cleared
    2009-03-20

    (233 days)

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

    INTELAMETRIX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (1) BodyMetrix BX2000 is indicated for the measurement of localized fat layer thickness and localized muscle thickness. When used with the BodyView Software it can be used to estimate total body fat percentage (%BF). The BX2000 is only intended to be used on generally healthy adults and children (6 or older) and is not for diagnosis of disease or condition. (2) The BodyView Software is indicated for the calculation of the estimated total body fat percentage (%BF), localized fat layer thickness, and localized muscle thickness. The BodyView Software is indicated for calculating Waist-to-Hip Ratio (WHR), and Body Mass Index (BMI). The Body View Software is indicated for estimating Basal Metabolic Rate (BMR). The Body View software can track changes in the measurements, and generate body composition reports.
    Device Description
    BodyMetrix BX2000™ is a portable, hand-held device that uses A-mode ultrasound to measure tissue thickness. The device is powered and communicates with a portable or desktop computer through a USB interface. A piezoelectric transducer is used to generate and transmit ultrasound. sound waves into tissue. The reflected sound waves are detected by a second and separate piezoelectric transducer and digitized before the data is transferred through a USB cable to the computer.
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