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510(k) Data Aggregation

    K Number
    K100350
    Device Name
    HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2010-03-22

    (38 days)

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

    HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT

    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

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Hoveround Teknique GT Powered Wheelchair. It does not contain the acceptance criteria, study details, or performance data of the device.

    Therefore, I cannot answer your request based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the technical performance specifications or study results you are asking for.

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