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510(k) Data Aggregation

    K Number
    K071761
    Device Name
    LLOYD LINDEN, MODEL E04
    Manufacturer
    LLOYD LINDEN, INC.
    Date Cleared
    2007-08-03

    (35 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K061726
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LLOYD LINDEN EO4 power standup wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between. It provides indoor and outdoor mobility.

    Device Description

    The LLOYD LINDEN EO4 power standup wheelchair is an indoor/outdoor power stand up wheelchair that is battery operated. The design of this wheelchair is basically similar to other power stand up wheelchairs that are already on the market. It consists primarily of a welded steel frame, transaxle motor drive system, braking system and electronic motor controller and is powered by two 12 volt DC batteries, and utilize a charger.

    AI/ML Overview

    The provided text pertains to a 510(k) summary for a medical device (a power standup wheelchair) and does not describe any acceptance criteria or a study that proves the device meets those criteria. The submission establishes substantial equivalence to a predicate device based on similar design and intended use, noting only minor performance differences that do not alter function or raise new safety/effectiveness questions.

    Therefore, I cannot extract the requested information as it is not present in the provided document.

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