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510(k) Data Aggregation
K Number
K171017Device Name
Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T
Manufacturer
Date Cleared
2017-10-18
(196 days)
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Convaid Products llc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Convaid Flyer models are manual wheelchairs; they are intended to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
In addition the Flyer Transit models FL12T. FL14T. FL15T and FL16T comply with the requirements of RESNA WC4:2012 section 19 Wheelchairs used as seating in motor vehicles.
Device Description
The Flyer series are attendant propelled manual wheelchairs constructed of the same materials and contain the same typical components and accessories found on most manual attendant propelled wheelchairs. The product consists of high strength powder coated tubular aluminum and steel plates that are welded, brazed, riveted or bolted. It comes standard with 5.5' front wheels attached to pivoting casters for steering and turning and 11.5" wheels in the rear. The product has a lightweight rigid base with a folding removable seating module, which is designed for everyday indoor or outdoor use on flat firm terrain. The Flyer offers its users a -5° to 40° range of continuously adjustable tilt-in-space achieved through the use of a single mechlok and hand lever to control the tilt action and 80° to 170°of seat to back adjustment (recline) that is controlled with a hand activated two plunger type pin system and plates on each side of the seating module with 10° incrementally located holes, the plungers pins engage to maintain the desired degree of recline. The chair comes standard with seat and back cushions that meet the requirements of WC1 section 16 for flammability and ISO 10993 biological evaluation of medical devices. However, the user also has the option of using a commercially available compatible seat and back cushion. The seat depth is set at the factory to one of four (4) depths and an adjustable back height of 17 to 23 inches. Positioning accessories include a two point belt or three point belt with crotch pad, foot positioners, H-harness with padded covers, adjustable footplate, head support and adjustable headwing, flip-up armrests and LTV bracket. The Flyer Transit models are WC4:2012 section 19 transit approved for use as a seating in motor vehicles.
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