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510(k) Data Aggregation

    K Number
    K023166
    Device Name
    WU'S 3-WHEELED NEO SCOOTER, WT-M4
    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-M4

    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 marketing clearance letter from the FDA for a device called "Wu's Three-Wheeled Neo Scooter, WT-M4" (though the Indications for Use refers to it as "Wu's 4-Wheeled Neo Scooter, WT-M4"). This is a physical medical device, specifically a motorized three-wheeled vehicle intended to provide mobility to persons restricted to a seated position.

    The request asks for information relevant to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device. This document does not contain any information about acceptance criteria or studies related to AI or algorithms. Instead, it is a statement of substantial equivalence to predicate devices for a physical product based on the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

    Therefore, I cannot provide the requested information from the given text as it is not applicable to the type of device described in the prompt.

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