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510(k) Data Aggregation

    K Number
    K030427
    Device Name
    HP-3 HD ELECTRIC WHEELCHAIR
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2003-04-18

    (67 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Special
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K011745
    Why did this record match?
    Device Name :

    HP-3 HD ELECTRIC WHEELCHAIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the IMC-Heartway HP-3 HD wheelchair is to provide mobility to adults, limited to a sitting position and have the capability to operate a simple hand control.

    Device Description

    Model HP-3 HD Electric Wheelchair

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an electric wheelchair. It does not contain information about the acceptance criteria or a study that proves a device meets those criteria, as it pertains to AI/ML or diagnostic devices.

    The document is a regulatory approval for a physical medical device (a powered wheelchair) and focuses on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results in the context you've described.

    Therefore, I cannot extract the requested information from this document.

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