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510(k) Data Aggregation

    K Number
    K032489
    Device Name
    WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2003-09-24

    (43 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 4-WHEELED NEO SCOOTER, WT-M4JR

    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

    WU'S 4-WHEELED NEO SCOOTER, WT-M4Jr

    AI/ML Overview

    I'm sorry, but this document is a 510(k) clearance letter from the FDA for a "WU's 4-Wheeled Neo Scooter, WT-M4Jr," which is classified as a "Motorized Three-Wheeled Vehicle."

    The provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to a medical device's performance evaluation using AI or clinical studies.

    The letter simply states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include any performance data or study details that would be necessary to answer your questions.

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