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510(k) Data Aggregation

    K Number
    K963385
    Device Name
    QUICKIE POWER WHEELCHAIRS P200 SERIES
    Manufacturer
    QUICKIE DESIGNS, INC.
    Date Cleared
    1997-04-28

    (244 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

    Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.

    Device Description

    Quickie powered wheelchairs consist of typical features found on any wheelchair, such as push handles, adjustable armrests, backrest, seat frame and cushion, footrests, and casters. Because these are motorized wheelchairs, they also consist of joy stick controller, motors, brakes, batteries and drive wheels.

    AI/ML Overview

    This document is a 510(k) premarket notification for a change in the controller of an existing powered wheelchair. It does not describe a study involving "acceptance criteria" and "device performance" in the context of typical AI/ML medical device evaluations.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device due to a controller change, not on evaluating the performance of a new AI/ML algorithm against predefined metrics.

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