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510(k) Data Aggregation

    K Number
    K971873
    Manufacturer
    Date Cleared
    1997-07-03

    (44 days)

    Product Code
    Regulation Number
    890.3900
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LEVO ACTIVE-EASY LAE

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

    The LEVO stand-up wheelchair is a product which changes position from seating to standing and standing to seating.
    Target population: For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

    Device Description

    Design: A manual stand-up mechanism is integrated in a manual driven wheelchair which allows the user to stand up easily when and where ever he wants to.
    Material: Main frame: Colour painted aluminium. Major stressed parts: Reinforced brass casting. Upholstery: Flame impeded.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called "LEVO active-easy LAE", which is a stand-up wheelchair.

    The document primarily states that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory information and responsibilities. It includes the indications for use and a brief description and performance claim for the device, but this is not a detailed study report or a list of acceptance criteria.

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

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