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510(k) Data Aggregation

    K Number
    K042920
    Device Name
    HOVEROUND SE-3 POWERCHAIR
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2004-12-03

    (42 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 SE-3 POWERCHAIR

    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

    Hoveround SE-3 Powerchair

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a powered wheelchair, the "Hoveround SE-3 Powerchair." This document does not describe acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any of the specific details requested regarding sample sizes, ground truth establishment, or expert involvement.

    Instead, this document is an administrative notification that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements and provides contact information for further guidance.

    Therefore, I cannot provide the requested information based on the input text.

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