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510(k) Data Aggregation

    K Number
    K023942
    Device Name
    CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311
    Manufacturer
    Date Cleared
    2003-02-24

    (90 days)

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

    YAMATO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Yamato ClockMINI and ClockNAVI Body Fat Monitors are intended for use in the estimation of body fat percent in users between the ages of 10 and 80 years old.
    Device Description
    The Yamato ClockMINI Body Fat Monitor -- DF301 (ClockMINI) is an over-the-counter body composition analyzer and clock that uses Bioelectrical Impedance Analysis (BIA) to estimate body fat percent by measuring the electric resistance sensed when a 50kHz/500 µ A current is passed through the body. From this measurement the device uses an algorithm to display an estimate of body fat percent. In addition, the ClockMINI classifies the body fat percent into one of four categories: low, average, high, and very high. The Yamato ClockNAVI Body Fat Monitor - DF311 (ClockNAVI) is an over-the-counter body composition analyzer and clock that uses Bioelectrical Impedance Analysis (BIA) to measure body fat percent by measuring the electric resistance sensed when a 50kHz/500 µ A current is passed through the body. From this measurement the device uses an algorithm to display an estimate of body fat percent and a classification of obesity level. The device also calculates Body Mass Index (BMI) from data input by the user and displays an obesity level classification based on the calculated BMI.
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