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510(k) Data Aggregation

    K Number
    K082246
    Device Name
    DIGNITY 100
    Manufacturer
    DIGNITY MEDICAL DEVICES, INC
    Date Cleared
    2008-09-09

    (32 days)

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

    DIGNITY MEDICAL DEVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. To provide mobility for the disabled.
    Device Description
    The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. The Dignity 100 functions like a standard mechanical wheelchair with the addition of a custom cushion. This 21 CFR Sec. 890.3920 wheelchair component is intended for medical o rurgoses and surface an integral part of the wheelchair, but will also be sold separately as a replacement part. The custom cushion is designed with a keyhole shaped drop down panel which is replacement by the patient when he or she wishes to use the toilet. The Dignity 100 is constructed from 7/8 inch outside diameter (OD) round, mechanical steel tubing. The chair is of welded construction. The sewn components are secured to the frame using screws and bolts. This device is a rigid wheelchair that incorporates a seating surface. The Dignity 10 has removable footrests.
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