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510(k) Data Aggregation

    K Number
    K040457
    Device Name
    NOMAD FROM DYNAMIS MOBILITY LTD.
    Manufacturer
    DYNAMIS MOBILITY LTD.
    Date Cleared
    2004-05-19

    (86 days)

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

    INTENDED USE OF THE NOMA'S POWERED THE WHEELCHAIR IS TO PROVIDE SAFE PERSONAL HOBILITY TO PERSONS LIMITED TO A SEATED OPERATING A WITC ARE CAPABLE OF POSITION POWERED WHEELLHAIR

    Device Description

    Nomad Powered Wheelchair

    AI/ML Overview

    This is an FDA 510(k) clearance letter for a powered wheelchair (Nomad Powered Wheelchair, K040457). This type of document does not contain the information requested regarding acceptance criteria and formal study results for device performance.

    FDA 510(k) clearances establish substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. They typically do not require the rigorous clinical trial data or detailed performance studies that would be submitted for a Pre-Market Approval (PMA) application or a de novo classification.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence, not detailed performance metrics and study designs as would be found in a clinical study report or a more extensive technical file.

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