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510(k) Data Aggregation

    K Number
    K042033
    Device Name
    HOVEROUND POWER WHEELCHAIR, MODEL HD700
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2004-09-29

    (62 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 POWER WHEELCHAIR, MODEL HD700

    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 does not contain the information requested for acceptance criteria and the study details.

    The provided text is a 510(k) clearance letter from the FDA for a powered wheelchair (Hoveround Power Wheelchair, model HD700). It states that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.

    However, this letter does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Details about a specific study, including sample sizes, data provenance, ground truth establishment, or expert qualifications.
    3. Information on MRMC studies or standalone algorithm performance, as it's a physical medical device, not an AI/software device.

    The letter primarily focuses on the regulatory clearance for the device based on substantial equivalence, not on the detailed results of a performance study against specific acceptance criteria.

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