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510(k) Data Aggregation

    K Number
    K063203
    Device Name
    ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2007-02-13

    (113 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Abbreviated
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)

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

    The intended use of the Rumba S (HP4) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for a powered wheelchair. It confirms that the device, the IMC-Heartway, LLC Model Rumba S (HP4), is substantially equivalent to a legally marketed predicate device.

    However, this document does not contain any information about acceptance criteria, device performance, study details (sample sizes, expert qualifications, adjudication methods, ground truth, MRMC studies, or standalone performance), or training set information.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is not present in the provided text.

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