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510(k) Data Aggregation

    K Number
    K990484
    Device Name
    INDEPENDENCE 324
    Manufacturer
    EAGLE PARTS & PRODUCTS, INC.
    Date Cleared
    1999-06-25

    (129 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 INDEPENDENCE 324 IS INTENDED TO AID IN THE TEMPORARY OR PERMANENTLY MOBILITY IMPAIRED INDIVIDUAL TO MOVE ABOUT INDOORS, AND OUTDOORS, THROUGH THE USE OF A BATTERY POWERED, MOTORIZED THREE-WHEELED VEHICLE. THE WEIGHT CAPACITY OF THE INDIVIDUAL IS NOT TO EXCEED 300 LBS.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA premarket notification (510(k)) letter for the "INDEPENDENCE 324" and "INDEPENDENCE 624" devices. This document does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory clearance letter indicating that the FDA has found the devices substantially equivalent to previously marketed devices.

    Therefore, I cannot provide the requested information based on this document.

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