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510(k) Data Aggregation

    K Number
    K023993
    Device Name
    GALAXY SERIES WHEELCHAIR
    Manufacturer
    EVERMED CORP.
    Date Cleared
    2002-12-27

    (24 days)

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

    EVERMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galaxy Series Wheelchair provides enhanced mobility to physically challenged Persons limited to a sitting position.
    Device Description
    The Galaxy Series Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles. The Galaxy Series Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of metal frame constructed of round steel tubing that is welded, seat and back upholsteries, removable footrests, front casters and rear wheels. The upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy. The users manual of Galaxy Series Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.
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    K Number
    K024030
    Device Name
    MILLENNIUM SERIES MANUAL WHEELCHAIRS
    Manufacturer
    EVERMED CORP.
    Date Cleared
    2002-12-12

    (6 days)

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

    EVERMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Millennium Series Mechanical Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.
    Device Description
    The Millennium Series Wheelchair is manually operated mechanical wheelchair. It is designed to be durable with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles. The Millennium Series Mechanical Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of metal frame constructed of round steel tubing that is welded, seat and back upholsteries, removable footrests/legrests, front casters and rear wheels. The upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.
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    K Number
    K023485
    Device Name
    EXPLORER POWERED WHEELCHAIR
    Manufacturer
    EVERMED CORP.
    Date Cleared
    2002-12-02

    (46 days)

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

    EVERMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Explorer™ Powered Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.
    Device Description
    The Explorer™ Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The product has a metal frame with four wheels, an adjustable seat with armrests, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for transport and is provided with a battery charger.
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