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510(k) Data Aggregation

    K Number
    K111278
    Device Name
    Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
    Manufacturer
    OTTO BOCK HEALTHCARE, LP
    Date Cleared
    2011-09-16

    (134 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K073701
    Why did this record match?
    Device Name :

    Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE

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

    Provide mobility to persons physically challenged and limited to sitting positions due to:

    • Palsies/Paralyses .
    • Loss of limbs
    • Defective and/or deformed limbs ●
    • Joint contractures .
    • Joint defects ●
    • . Other diseases
    Device Description

    The z10 is a powerful push and brake assist for manual wheelchairs. It can also be converted into the z10-ce add-on drive with tiller control quickly and easily. In this product version, the user drives and controls the wheelchair independently.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

    The document is a 510(k) summary for a physical medical device, the "z10 Push and Brake Assist," which is a powered wheelchair mover. The safety testing mentioned refers to physical product standards compliance (e.g., ISO, ANSI/RESNA) for a hardware device, not performance metrics for an AI system.

    Therefore, I cannot provide the requested information, as it is not present in the given document.

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