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510(k) Data Aggregation

    K Number
    K023581
    Device Name
    COMFORT AGILE SCOOTER, LY-EW303
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2002-12-02

    (39 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COMFORT AGILE SCOOTER, LY-EW303

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a motorized three-wheeled vehicle (Comfort Agile Scooter, LY-EW303). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The text does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Details on sample sizes, data provenance, or study design.
    3. Information about experts, ground truth establishment, or adjudication methods.
    4. Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot provide the requested information.

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