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510(k) Data Aggregation

    K Number
    K102910
    Device Name
    MODEL LUNA MANUAL WHEELCHAIR
    Manufacturer
    Date Cleared
    2010-12-23

    (83 days)

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

    P.D.G., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide mobility to persons limited to a seated position.
    Device Description
    The PDG Model Luna wheelchair is manually operated, self propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons that may be limited to a seated position. It may also be used as attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility.
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