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510(k) Data Aggregation

    K Number
    K031342
    Date Cleared
    2003-07-10

    (73 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    N/A
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Model Seeker II, is to provide mobility to adults in rough terrain, with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.

    Device Description

    Model Seeker II, Electric Power Wheel Chair

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a power wheelchair and an "Indications for Use Statement". It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications that would allow me to answer your request.

    The text is a regulatory document confirming that the "Model Seeker II, Electric Power Wheelchair" is substantially equivalent to a legally marketed predicate device. It defines the intended use and indications for use of the wheelchair. While regulatory clearance often relies on testing, the details of those tests are not present in this document.

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