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510(k) Data Aggregation

    K Number
    K072153
    Date Cleared
    2007-09-10

    (38 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUICKIE QX MANUAL FOLDING WHEELCHAIR

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

    The Sunrise Medical Quickie QX Manual Folding Mechanical Wheelchair's intended use is to provide mobility to persons restricted to a sitting position. The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels that is intended for medical purposes which provides an optional means of mobility for physically challenged people. The mechanical wheelchair is indicated for physically challenged individuals and can provide a means of mobility.

    Device Description

    The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels.

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a manual folding wheelchair. It does not contain information about acceptance criteria, device performance tables, or a study demonstrating that the device meets acceptance criteria as described in your request.

    The provided text only contains:

    • A decision letter from the FDA indicating that the Sunrise Medical Quickie QX Manual Folding Wheelchair has been found substantially equivalent to a legally marketed predicate device.
    • Indications for Use Statement for the Quickie QX Manual Folding Wheelchair.

    Therefore, I cannot extract the requested information points (1-9) from this document. This typically falls under a different section of a 510(k) submission, such as a "Summary of Non-Clinical Tests" or "Performance Testing" section, which is not present in the provided text.

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