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510(k) Data Aggregation

    K Number
    K242139
    Device Name
    Mobility Scooter (YL-09B, YL-07)
    Manufacturer
    Yongkang Yile Vehicle Co.,Ltd
    Date Cleared
    2025-01-06

    (168 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Mobility Scooter (YL-09B, YL-07)

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

    It 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

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a Mobility Scooter. It is a regulatory document and does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the given input. This document is a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices, not a study report detailing performance metrics.

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