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510(k) Data Aggregation
K Number
K103212Device Name
ROUGHRIDER
Manufacturer
Date Cleared
2011-01-03
(63 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
WHIRLWIND WHEELCHAIR INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RoughRider is indicated to provide mobility to persons restricted to a seated position. The wheelchait is indicated for a weight capacity of up to 220 lbs.
Device Description
The Whirlwind RoughRider® is a user propelled, manually operated folding wheelchair. The Whirlwind RoughRider has not previously been submitted to the FDA for clearance. The Whirlwind RoughRider utilizes carbon steel tubing (STKM 11 AC) that is bent, fastened and/or welded to create a frame. An X-Brace connects the left and right mono frame (single piece side frame design) side frames of the wheelchair together and serves as the mechanism that allows the frame to fold. A set of adjustable axle sockets are attached to each side frame which provide the wheelchair with ability to move the rear wheel position forward and backward to give the user an adjustment as to the center of gravity of the wheelchair. Front casters (hubs and tires) are connected to a fork that is fastened to the front frame of the caster housing. The front casters of the RoughRider are positioned approximately five inches further forward than most wheelchair designs, which gives the user of the RoughRider a very stable ride in terms of forward stability. The RoughRider is intended for use on smooth indoors surfaces and outdoor surfaces which require additional forward stability such as pocked dirt and uneven pavement. The nylon upholstery back and seat meets EN 1021-2: Flammability Testing with Match and Cigarette.
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