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510(k) Data Aggregation
K Number
K120391Device Name
MR4500 WHEELCHAIR
Manufacturer
Date Cleared
2012-12-21
(318 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
WARDRAY PREMISE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MR4500 is an adult Manual Mechanical Wheelchair intended to provide mobility to person limited to the sitting position as a transport chair within a healthcare facility.
Device Description
The Wardray Premise MR 4500 is a manually operated wheelchair that is propelled by human power. Its intended function and use is to provide mobility to person limited to a sitting position. It may be used as an attendant propelled transport device in a healthcare environment such as a hospital, nursing home or extended care facility. The wheelchair consists primarily of an aluminum frame; 12inch rear wheels and 5-inch front casters and handles for the wheelchair to be pushed. It is folding or non-rigid type of wheelchair that is designed for use by a patient weighing up to 280 lbs. The frame is constructed of one inch (1) outside diameter Aluminum tube that is welded that has a wall thickness of 1/8 inch. The rear urethane wheels are fixed and front are urethane casters.
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