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510(k) Data Aggregation

    K Number
    K020536
    Device Name
    GAZELLE WHEELCHAIR
    Manufacturer
    ALUM CREEK WHEELCHAIR CO., INC.
    Date Cleared
    2002-03-15

    (24 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GAZELLE WHEELCHAIR

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

    The Gazelle Wheelchair is a lightweight manual wheelchair designed for individuals who need assistance in transportation. It provides mobility based upon an individual user's needs and capabilities.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a mechanical wheelchair, specifically the "Gazelle Wheelchair." It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, the input document does not contain any information regarding acceptance criteria or a study proving device performance in the context of medical efficacy or diagnostic accuracy. This type of information would typically be found in a clinical study report or a pre-submission document detailing performance metrics.

    As a result, I cannot provide the requested information. The document is strictly a regulatory clearance notice and lacks the details about performance studies.

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