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510(k) Data Aggregation

    K Number
    K021255
    Device Name
    Y.E.S 10 WHEELCHAIR
    Manufacturer
    MOVINGPEOPLE.NET
    Date Cleared
    2002-05-02

    (13 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the movingpeople.net Y•e•S is to provide mobility to persons limited to a seated position and that have the capability of operating a powered wheelchair.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair named "Y.e.S." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the document is a regulatory approval letter and DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document focuses solely on the regulatory approval process and not on the technical performance evaluation that would typically include such details.

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