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510(k) Data Aggregation

    K Number
    K990122
    Device Name
    INDEPENDENCE 624
    Manufacturer
    EAGLE PARTS & PRODUCTS, INC.
    Date Cleared
    1999-06-25

    (163 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    the temp permanently mobility impaired individual to move about in doors, and out through the use of a battery powere wheeled device. Weight capacity individual not to exceed 250 l

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA, and it does not contain any information regarding device acceptance criteria, study data, or performance metrics. It simply states that the devices (Independence 624 and Independence 324) are substantially equivalent to previously marketed devices.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided document.

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