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510(k) Data Aggregation

    K Number
    K052681
    Device Name
    START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2005-10-06

    (8 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 :

    START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)

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

    Persons who are unable to walk or who have a walking impediment.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for a manual wheelchair, which is a physical device, not a digital health device or an AI/ML-driven device. As such, it does not contain the information required to answer the questions about acceptance criteria, study details, ground truth, or AI/ML performance.

    Therefore, I cannot extract the requested information from this document.

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