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510(k) Data Aggregation
K Number
K042401Device Name
VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
Manufacturer
Date Cleared
2004-10-07
(34 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN TRACK ROADSTERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Vari-Able, APB (Adaptable Positioning Base) mechanical wheelchair is to provide mobility to persons with a primary pediatric indication who are limited to a sitting position.
Device Description
The Vari-Able, APB (Adaptable Positioning Base) is a manually operated, attendant controlled, manual, mechanical wheelchair and patient positioning system. It is designed to provide mobility and optimized positioning for patients who require long term accommodation due to conditions of severe physical motion restriction. Patients with diagnosis such as cerebal palsy, would typically benefit from the use of the Vari-Able, APB (Adaptable Positioning Base).
The product consists of a steel/aluminum frame, rear wheels (which can be substituted based on patient requirements), a seat pail, from with adjustments for seating configuration, and manual brakes, anti-tip wheels, footrests, and other components such as head and trunk support, and other components as needed. The APB will accommodate the positioning and seating systems currently available in the market.
The product is capable of many configurations of the frame, wheels, and components to accommodate patients with difficult to solve positioning requirements. Using the manual adjustments that can be made to the frame, the angle of the chair may be changed to accommodate the patient's needs.
The Vari-Able APB (Adaptable Positioning Base) also features weight shifting capabilities using manual tilt-in-space and recline features. This also can assist in positioning and feeding.
The product is designed to function indoors or outdoors on surfaces such as sidewalks and other public places.
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