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510(k) Data Aggregation

    K Number
    K023040
    Device Name
    WU'S 3-WHEELED NEO SCOOTER, WT-L3
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2003-01-24

    (134 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-L3

    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 3-Wheeled Neo Scooter, WT-L3

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a "Wu's 3-Wheeled Neo Scooter, WT-L3," which is classified as a "Motorized, three-wheeled vehicle."

    This document does not contain any information about:

    • Acceptance criteria or device performance for medical imaging or AI analysis.
    • Sample sizes for test sets or training sets.
    • Data provenance, expert qualifications, or ground truth establishment.
    • Adjudication methods.
    • MRMC comparative effectiveness studies or standalone algorithm performance.

    The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for providing mobility to persons restricted to a seated position. It pertains to a physical medical device, not a software or AI-driven diagnostic tool.

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