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510(k) Data Aggregation

    K Number
    K043511
    Device Name
    SOLEUS POWERED WHEELCHAIR, MODEL FAD-2
    Manufacturer
    SOLEUS CHAMP INTERNATIONAL CO., LTD.
    Date Cleared
    2005-03-14

    (84 days)

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

    SOLEUS CHAMP INTERNATIONAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The SOLEUS POWERED WHEELCHAIR, FAD-2 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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