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510(k) Data Aggregation

    K Number
    K993963
    Device Name
    SIGMA MANUAL WHEELCHAIR
    Manufacturer
    SIGMA DISTRIBUTION & SUPPLY, INC.
    Date Cleared
    2000-01-13

    (52 days)

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

    **SIGMA DISTRIBUTION **& SUPPLY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For transportation of disabled persons.
    Device Description
    The device consists of a chromed steel frame with cross bars, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests. Front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.
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