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510(k) Data Aggregation

    K Number
    K043069
    Device Name
    HOVEROUND E100 POWER CHAIR
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2004-12-03

    (25 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 E100 POWER CHAIR

    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 510(k) premarket notification approval letter for the Hoveround E100 Powerchair. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance metrics for the device itself.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text. The document focuses on the regulatory approval process and states the intended use of the powerchair, but does not include technical specifications, performance evaluation data, or ground truth details.

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