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510(k) Data Aggregation

    K Number
    K100527
    Device Name
    HOVEROUND TEKNIQUE, MODEL HD-6
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2010-03-26

    (30 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Special
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HOVEROUND TEKNIQUE, MODEL HD-6

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

    The intended use is to provide mobility to persons limited to a seated position.

    Device Description

    Hoveround Teknique HD-6 Power Wheelchair

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA for a power wheelchair, the Hoveround Teknique HD-6 Power Wheelchair. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It refers to regulations governing manufacturing practices, labeling, and adverse event reporting, but there is no mention of an algorithm or AI component, nor any performance study details as typically found for AI/ML devices.

    Therefore, I cannot provide the requested information based on the provided document.

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