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510(k) Data Aggregation

    K Number
    K022700
    Device Name
    DELUXE MANUAL WHEELCHAIR HW 4000
    Manufacturer
    FOREVER YOUNG ENT. CO., LTD.
    Date Cleared
    2002-09-13

    (31 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    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 device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    DELUXE MANUAL WHEELCHAIR HW4000

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter for a Deluxe Manual Wheelchair HW4000. It is a regulatory document from the FDA acknowledging substantial equivalence to a predicate device.

    This document does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth methodologies for an AI/ML powered medical device.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a manual wheelchair and not an AI-powered device. The questions posed are highly specific to AI/ML device evaluations, which are not applicable to the content of this document.

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