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510(k) Data Aggregation

    K Number
    K033646
    Device Name
    TRIFIT 700
    Manufacturer
    HEALTHFIRST CORP.
    Date Cleared
    2005-03-01

    (467 days)

    Product Code
    DRT
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHFIRST CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TriFIT 700M is a physical fitness assessment device which can be used in both The THFTF 700M IS a physical Inness assess for individuals to test and to measure their medical fitness levels. The assessment includes body weight, biceps strength, flexibility, phySical Intriess foven. "It estimate percentage body fat), and heart rate.
    Device Description
    The TriFIT 700M consists of the following components: - 1. A standard desktop computer to include the monitor, keyboard, mouse, and printer - Platform weight scale 2. - 3. Strength measuring handle - 4. Flexibility tester - 5. Skin-fold caliper - 6. Heart rate monitor These components all attach to an interface box. This interface box attaches to the computer via a serial cable. Some components are optional.
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