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510(k) Data Aggregation

    K Number
    K031289
    Device Name
    QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
    Manufacturer
    SUNRISE MEDICAL, INC.
    Date Cleared
    2003-05-09

    (16 days)

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

    QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424

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

    The Center Drive Power Wheelchair's intended use is to empower physically challenged individuals by providing a means of mobility.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) summary for the "Center Drive Power Wheelchair" (K031289) does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth establishment, expert involvement, or training sets.

    This document is a letter from the FDA confirming the substantial equivalence of the device to legally marketed predicate devices, and an "Indications for Use Statement." It does not include the detailed technical and performance data that would typically be found in a study report.

    Therefore, I cannot provide the requested information based on the text you provided.

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