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510(k) Data Aggregation

    K Number
    K023168
    Device Name
    WU'S 3-WHEELED NEO SCOOTER, WT-T3B
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2003-01-24

    (123 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 :

    WU'S 3-WHEELED NEO SCOOTER, WT-T3B

    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 acceptance criteria, device performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

    The text is a U.S. FDA 510(k) clearance letter for a "Wu's 3-Wheeled Neo Scooter, WT-T3B." It primarily focuses on the regulatory determination of substantial equivalence to a predicate device and outlines the general controls and regulations applicable to the product. It states the indications for use as "The device is intended for medical purposes to provide mobility to persons restricted to a seated position."

    The letter does not include any technical or clinical study details that would allow me to answer your specific questions regarding performance metrics or study design.

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