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510(k) Data Aggregation

    K Number
    K032512
    Device Name
    Y.E.S POWERED WHEELCHAIR. T180
    Manufacturer
    YEOU EIR SHUEN MACHINERY CO., LTD.
    Date Cleared
    2003-11-12

    (90 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Y.E.S POWERED WHEELCHAIR. T180

    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 sitting position.

    Device Description

    Y.E.S. Powered Wheelchair, T180

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a powered wheelchair (Y.E.S. Powered Wheelchair, T180). This type of document declares substantial equivalence to a predicate device and allows market entry. It does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment—these are typically found in the 510(k) submission itself, which is not provided here.

    Therefore, I cannot answer your request based on the provided text. The document is administrative in nature, confirming regulatory clearance.

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