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510(k) Data Aggregation

    K Number
    K993298
    Device Name
    E Z CHAIR
    Manufacturer
    PREMIER DESIGNS
    Date Cleared
    1999-11-16

    (46 days)

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

    The EZ Chair will be used, like a Sunrise Medical Quickie 2 HP wheelchair in the Hemi Height position, to aid the temporarily or permanently mobility impaired individual to move about indoors, and outdoors, through the use of a wheeled device (wheelchair). You can propel yourself by pushing along the ground with your feet or you can propel yourself by pushing the pedals. Like a Hemi Height chair, the EZ Chair will be used by people with limited use of their legs due to conditions such as: Arthritis, Single leg Amputee, Multiple Sclerosis, Muscular Dystrophy, Hemiplegic, Parkinson's Disease, Emphysema, Geriatric, Cerebral Palsy, Head Injury, Post Polio, etc.

    Device Description

    EZ CHAIR

    AI/ML Overview

    I am sorry but this document does not contain the information you requested regarding acceptance criteria and study details for the EZ Chair. The provided text is a 510(k) clearance letter from the FDA, which outlines the regulatory approval for the device based on substantial equivalence to a predicate device. It does not include specific performance studies or acceptance criteria beyond indicating its intended use.

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