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510(k) Data Aggregation

    K Number
    K023574
    Device Name
    GIZMO
    Manufacturer
    FREEDOM DESIGNS, INC.
    Date Cleared
    2002-12-04

    (41 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

    This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "Gizmo," which is a mechanical wheelchair. This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it is not an AI/ML medical device submission.

    The document explicitly states: "This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users." This indicates that the "Gizmo" device is a simple mechanical device, not a sophisticated diagnostic or AI-powered tool.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML device, as this document is not relevant to such a request.

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