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510(k) Data Aggregation

    K Number
    K030757
    Device Name
    COACH 777-4
    Manufacturer
    WHEELCHAIR & SCOOTER EXPRESS
    Date Cleared
    2003-10-06

    (209 days)

    Product Code
    INI
    Regulation Number
    890.3800
    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 intended use of this product is to offer another choice of mobility to physically challenged people.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria and study details you are asking for. The document is a 510(k) clearance letter from the FDA for a motorized three-wheeled vehicle named "Coach 777-4". It confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It does not include information about performance studies, test sets, ground truth, or expert qualifications.

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