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510(k) Data Aggregation

    K Number
    K021145
    Device Name
    ACCOMMODATOR WHEELCHAIR, MODEL #2000X
    Manufacturer
    MARKEN INTERNATIONAL, INC.
    Date Cleared
    2002-05-16

    (37 days)

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

    MARKEN INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A mechanical wheelchair is indicated for persons restricted to a sitting position. Conditions causing this would include but not be limited to arthritis, amputee, paraplegic, multiple sclerosis, polio, quadriplegic, cerebral palsy, spina bifida, head injury or trauma, muscular dystrophy, and geriatric conditions.
    Device Description
    Not Found
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