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510(k) Data Aggregation
K Number
K090350Device Name
EXTREME 4X4-X8 POWER WHEELCHAIR
Manufacturer
Date Cleared
2009-04-10
(58 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
VESTIL MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the X8 power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair.
Device Description
The Extreme 4x4- X8 is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a four-wheel drive format wheelchair as its basic configuration with direct drive motors on all four wheels. The wheelchair frame is a non-folding type. The frame of the unit is of welded steel construction. The wheelchair consists of the following basic components: frame w/four motors, joystick, seat, armrests, and footrests.
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K Number
K030783Device Name
FRONTIER MODEL X5
Manufacturer
Date Cleared
2003-04-04
(23 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
VESTIL MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indended use of the Frontier Power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair
Device Description
The Frontier Power Wheelchair is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a mid wheel drive format wheelchair as it's basic configuration with direct drive motors and four swivel castors. The wheelchair frame is of a non-folding type with a mid mounted drive wheels on individual, front pivoting extension arms ending in front mounted swivel castors. The rear of the main frame ends with a lateral pivoting beam arm with swivel castors mounted on each side. This frame design allows for all 6 wheels to contact the ground over uneven terrain.
The frame consists of a combination of 2" diameter round steel tube. 1 ¼" diameter round steel tube and 1 ¼" square tube. The wheelchair consists of the following basic components: frame with articulated drive wheels and casters, seat, armrests, and footrests.
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K Number
K021866Device Name
KARMA 800 SERIES MANUAL WHEELCHAIR
Manufacturer
Date Cleared
2002-06-14
(8 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
VESTIL MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THE INTENDED USE OF THE KARMA 800 SERIES MANUAL WHEELCHAIR IS TO PROVIDE MOBILITY TO PERSONS LIMITED TO A SITTING POSITION.
Device Description
The Karma 800 Series Manual Wheelchair is a user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position.
The product is designed to be a lightweight, everyday wheelchair for both indoor use. It is a folding, or non-rigid type of wheelchair. The product consist primarily of an aluminum allov frame with cross braces, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning.
The frame is constructed of round, aluminum alloy tubing that is welded. The seat-to-floor heights are adjustable via dual rear axle positions. The slung fabric seat and back meets the requirements of California 117 specifications for flame retardancy. Swing back armrest and swing away footrest are standard features.
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K Number
K014127Device Name
KARMA DISCOVERY, MODEL KP40
Manufacturer
Date Cleared
2002-03-15
(88 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
VESTIL MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.
Device Description
The Discovery power wheelchair is a battery powered, motorized mobility vehicle. The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.
The Discovery is designed to be durable, dependable, sporty and aesthetically appealing while being economically priced.
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K Number
K011374Device Name
JEWEL MPS
Manufacturer
Date Cleared
2001-05-29
(25 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
VESTIL MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000796Device Name
MAGIC MOBILITY 4 X 4 WHEELCHAIR
Manufacturer
Date Cleared
2000-08-11
(151 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
VESTIL MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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