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510(k) Data Aggregation

    K Number
    K984367
    Device Name
    ACTIVX
    Date Cleared
    1999-01-28

    (52 days)

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

    ADORNO ROGERS TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.
    Device Description
    The wheelchair is a standard lightweight manual folding chair that provides mobility based on an individual user's needs and capabilities. Since it has the same intended use as typical wheelchairs, its features are also comparable. A sling seat and backrest are affixed to a sturdy frame that is supported by two large rear wheels and two forward swivel caster wheels. The two side frames are connected by a horizontal cross brace, rather than a vertical cross brace, that can assume a folded configuration. The wheelchair accommodates removable armrests, detachable footrests, rear anti-tippers, push handles, and wheel locks.
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