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510(k) Data Aggregation
K Number
K023993Device Name
GALAXY SERIES WHEELCHAIR
Manufacturer
EVERMED CORP.
Date Cleared
2002-12-27
(24 days)
Product Code
IOR
Regulation Number
890.3850Why 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
K024030Device Name
MILLENNIUM SERIES MANUAL WHEELCHAIRS
Manufacturer
EVERMED CORP.
Date Cleared
2002-12-12
(6 days)
Product Code
IOR
Regulation Number
890.3850Why 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
K023485Device Name
EXPLORER POWERED WHEELCHAIR
Manufacturer
EVERMED CORP.
Date Cleared
2002-12-02
(46 days)
Product Code
ITI
Regulation Number
890.3860Why 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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