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510(k) Data Aggregation

    K Number
    K982750
    Device Name
    CORSAIRE
    Manufacturer
    OPTIWAY, INC.
    Date Cleared
    1999-02-01

    (179 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIWAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls. The device has similar features and uses as the predicated devices; "Jazzy" (K945936) Electric Powered Wheelchair manufactured by Pride Health Care. This device has the same intended use, safety and effectiveness as the predicated device mentioned.
    Device Description
    This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls.
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