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510(k) Data Aggregation

    K Number
    K984083
    Device Name
    MULTIFUNCTION KEITO K5
    Date Cleared
    2000-01-18

    (428 days)

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

    BUMEDCO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Multifunction KEITO K5 is intended to be used by adults in order to measure height, weight, systolic and diastolic blood pressures, and to calculate pulse rate.
    Device Description
    The Multifunction KEITO K5 (K5) is designed to provide the user with measurements of blood pressure, height, and weight, as well as to calculate the Body Mass Index (BMI) and pulse rate. The user is prompted to select a measurement cycle, step onto the K5 platform, and wait momentarily while the measurements and calculations are performed. After the measurements have been taken, the K5 provides the user with the results. To operate the K5 the user inserts a coin into the coin slot, and steps onto the platform. The user has the option of selecting a partial measuring cycle or a complete cycle. In a partial cycle, weight and height measurements are taken and Body Mass Index calculations are performed in the partial cycle. In a complete cycle, weight, height, blood pressure, and pulse measurements are taken. Body Mass Index is calculated and the W.H.O. blood pressure recommendations are provided. The K5 prints out a ticket containing the results of the measurements and the recommended ranges for both BMI and blood pressure.
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