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510(k) Data Aggregation
K Number
K200715Device Name
RoughRider Aurora Manual Wheelchair
Manufacturer
Date Cleared
2022-06-24
(828 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
RoughRider America LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RoughRider America™ RoughRider Aurora™ Manual Wheelchair is indicated to provide mobility to persons restricted to a seated position up to a weight capacity of up to 250 lb / 114 kg.
Device Description
The RoughRider America™ RoughRider Aurora™ Manual Wheelchair (Aurora) is a user propelled, manually operated folding wheelchair. The Aurora is designed for everyday use and to help its rider move around easily, safely, and without the restrictions imposed by much of the terrain encounter in daily life. The Aurora is expected to perform well:
- Indoors and outdoors; ●
- Over smooth, rough, and uneven ground; ●
- Over soft and hard surfaces; ●
- Over small obstacles, like door jams; and ●
- Up, down and across slopes. ●
The Aurora utilizes primarily aluminum tubing that is bent, fastened, and/or welded to create a frame. The frame is comprised primarily of side frame, X-brace, foot rest, and caster fork subassemblies. Upholstery is made from fire-resistance fabric. The rear wheels of the Aurora can be removed making the wheelchair lighter for lifting or carrying.
The side frames have three axle holes that allow the rear wheel position to be adjusted forward and backward. Wheel position affects the rider's forward and backward stability by changing wheel axle position relative to the person's center of gravity. The position of the rear wheel relative to the rider's center of gravity also affects the amount of the rider's weight that is distributed onto the front casters, and allows the rider to maximize maneuverability and control.
The Aurora side frame fenders act as fixed arm rests and enable transferring in and out of the wheelchair. The side frame also includes the backrest tubes and push handles. The backrest tubes can be adjusted up and down to meet basic support requirements of the rider and/or their companion. Wheel locks attach to the side frame and prevent the rear wheels from turning. The locks keep the wheels from moving during transfers or when a stationary position is necessary.
An X-Brace connects the side frames of the wheelchair together, determines the chair width, and allows the frame to fold. With the X-Brace in the unfolded position, the chair performs much like a typical X-Brace folding wheelchair. The Aurora can be easily folded for stowage or storage and fits easily into the cargo carrying areas of most vehicles.
The seat upholstery fastens to the top surface of each X-brace seat tube and provides support for the rider to sit. The angled, sling-style seat and tension-adjustable back fabric offers seating suitable for many different riders. The tilted seat helps keep the rider slightly reclined to reduce the chances of tipping forward and out of the chair. The back fabric can be adjusted to increase or reduce back fabric tension. The seat width of the Aurora is determined by the size of the x
brace and the seat fabric and fixed at the point of fabrication, based on the customer order. The seat can be used with a range of wheelchair and flotation (pressure relief) cushions.
The footrests are not easily removable and support the rider's lower legs or feet. The footrests are independently adjustable up and down to position the rider's legs appropriately. The footrests are hinged and can be folded up to enable easier transfers into and out of the Aurora. When the Aurora is unfolded, and the rider is sitting in the chair, the footrest design can give the rider added protection for their toes from doors or other obstacles.
The casters include the caster wheels (hubs and tires) and a caster fork. The caster is mounted to the front of the side frame using the caster barrel. The casters can turn freely 360°. The casters of the Aurora are positioned approximately five inches further forward than most hospital- or boxstyle wheelchair designs. This additional distance gives the rider of the Aurora a stable ride, in terms of forward stability.
To prevent unintended changes to the chair configuration and reduce risk to the rider, most adjustment (footrest and backrest height) require access to basic tools.
The maximum weight capacity of the chair is 250 lb (114kg).
The Aurora is based on and substantially equivalent to the established and tested design, of the Whirlwind RoughRider. This design has been refined with input from thousands of wheelchair riders around the world after over 15 years of use. The Aurora is easy to clean and uses a range of standardized components that are easy to maintain and replace.
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