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510(k) Data Aggregation

    K Number
    K112948
    Device Name
    JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
    Date Cleared
    2012-03-28

    (176 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The Jiangsu Healthy Way Aluminum Mechanical Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the resistant to ignition source smouldering cigarette, and match flame equivalent.
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