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510(k) Data Aggregation

    K Number
    K090108
    Device Name
    HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2009-03-19

    (63 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 FWD MK4 POWER WHEELCHAIR

    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

    The provided text is a U.S. FDA 510(k) clearance letter for a Hoveround Teknique FWD mk4 power wheelchair. This document is a regulatory approval for a physical medical device and does not contain information about an AI/ML device or its performance study.

    Therefore, I cannot extract any details regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not relevant to this type of medical device approval.

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