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510(k) Data Aggregation

    K Number
    K093946
    Device Name
    HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2010-03-22

    (89 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2

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

    The intended use is to assist transfer of an individual up or down a straight, residential, indoor staircase while in a seated position.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the Hoveround HoverGlide Stairlift. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for any medical device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document is a regulatory approval letter, not a scientific study report.

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