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510(k) Data Aggregation

    K Number
    K230615
    Device Name
    Electric Scooter (Model: S3312)
    Manufacturer
    Guangdong Prestige Technology Co., Ltd.
    Date Cleared
    2023-05-05

    (60 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 :

    Electric Scooter (Model: S3312)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    I is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

    Device Description

    Electric Scooter (Model: S3312)

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for an electric scooter and does not contain information about the acceptance criteria or a study proving device performance for a medical device that would have these types of criteria and studies associated with it.

    Therefore, I cannot extract the requested information.

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