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510(k) Data Aggregation
K Number
K052548Device Name
UROK ROCKING WHEELCHAIR, MODEL 700-4XX
Manufacturer
Date Cleared
2006-01-06
(112 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
AMG MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The URok Rocking Wheelchair is intended to provide mobility to persons limited to a sitting position while the rocking mechanism is locked in an upright position.
The wheelchair is intended to redistribute pressures exerted on the buttocks and lower back when rocking or tilted at an angle.
The wheelchair is intended to provide comfort adjustment while rocking or tilted at an angle.
Device Description
The AMG Medical Inc. URok Rocking Wheelchair is a manually operated, attendant or user propelled, mechanical rocking wheelchair. The device is a lightweight wheelchair, suitable for both indoor and outdoor use.
The device consists of an aluminum frame, one size of rear wheel, and smaller front pivoting casters for steering and turning. The frame is constructed from aluminum tubing that is TIG-welded. This device is a rigid, non-folding type of wheelchair that incorporates a padded, sling style seat. The upholstery meets the requirements of ISO 7176-16, flammability standards.
The AMG URok Rocking Wheelchair includes a rocking feature which permits dynamic pressure management of the seating pressure upon the buttocks. The rocking feature is realized by the placement of two vertically positioned fibrogless Ieaf springs, which are connected to the seat and frame, under the seat's centre of gravity. The balance of the seat upon the springs is precise enough so that the rocking motion may be initiated by the user simply by gently moving the head backward and forward. Safety features such as anti tippers and rock arrestors limit the arc of the rocking motion. The rocking feature can be "locked out" by an attendant so that the device can be used as a wheelchair with no rocking motion.
The AMG URok wheelchair also has a "tilts in space" feature. The rocking mcchanism can be locked in multiple positions to provide "tilt in space" that permits receing meemainst backwards thereby allowing gravity to hold them in position. This is used to help in positioning, comfort, or head control. The tilt in space is initiated by the attendant pushing down on the push handles to tilt the scat and back and locking out the rocking action when the desired angle of tilt is reached.
The rocking feature is released or is locked out by two cable controlled pins that insert into holes within two vertically mounted metal plates located under the seat support tubes. The cables are controlled using bicycle brake type levers in onto bed on the rear push tube or handle.
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