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510(k) Data Aggregation

    K Number
    K022369
    Device Name
    COMFORT WINDJOY SCOOTER, MODEL LY-EW302
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2002-10-11

    (81 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 WINDJOY SCOOTER, MODEL LY-EW302

    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

    This document is a 510(k) clearance letter from the FDA for a motorized three-wheeled vehicle (scooter) and does not contain the information needed to answer the questions about acceptance criteria and a study proving device performance. The letter simply states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the provided text.

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