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510(k) Data Aggregation

    K Number
    K231320
    Device Name
    Zhenjiang Assure Mechanical Wheelchair,model:K1
    Manufacturer
    Zhenjiang Assure Medical Equipment Co.,Ltd.
    Date Cleared
    2023-06-05

    (28 days)

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

    Zhenjiang Assure Medical Equipment Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.
    Device Description
    The Zhenjiang Assure Mechanical Wheelchair,model:K1 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 is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, the upholstery fabric meets the flame retardant test.
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