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510(k) Data Aggregation

    K Number
    K192658
    Device Name
    Manual Wheelchair
    Manufacturer
    Jerry Medical Instrument (Shanghai) Co., Ltd.
    Date Cleared
    2020-04-01

    (189 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K180852
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    The proposed device, Manual Wheelchair, driven by manual operation of rear tire, or pushed by caretaker. This product is mainly designed to be used to take care of the disabled or elderly, it is driven by manual operation of rear tire, or pushed by caretaker. The Manual Wheelchair consists of Frame, Footplate, Front castor, Rear wheel, Anti-tipper, Armrest, Brake, Central fork. The Manual Wheelchair has four models: JR201, JR202, JR203, JR204.

    AI/ML Overview

    The provided document is a 510(k) summary for a Manual Wheelchair and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the acceptance criteria or study details as requested for an AI device.

    The document discusses the mechanical wheelchair's specifications, non-clinical tests (meeting ISO standards), and a comparison to a predicate device to demonstrate substantial equivalence, but it does not mention any AI components, algorithms, or associated studies.

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