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510(k) Data Aggregation

    K Number
    K122707
    Device Name
    HOVERROUND TEKNIQUE
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2013-05-07

    (245 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 :

    HOVERROUND TEKNIQUE

    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 a powered wheelchair, the Hoveround Teknique XHD MK-V. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

    This means the clearance is based on substantial equivalence to a predicate device, not on a new study demonstrating performance against specific acceptance criteria. The FDA determined that the new device is as safe and effective as a previously cleared device. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, etc.) is not present in this document.

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