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510(k) Data Aggregation
K Number
K032879Device Name
NAVIGATOR I
Manufacturer
ADAPTIVE HEALTHCARE TECHNOLOGIES, INC.
Date Cleared
2003-11-13
(59 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
ADAPTIVE HEALTHCARE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide improved mobility, both indoors and outdoors, for persons who have adequate upper body strength suitable for manual steering, and who have a medical condition that impairs their ability to stand for periods of time or to walk.
Device Description
Navigator I was designed to assist individuals with limited mobility to maintain an active lifestyle. Its manual steering, high-torque four brush motor with rear wheel drive, large diameter (16") front wheels, high ground clearance (5.4"), full circle turning radius (27.5"), side to side anti-tip resistance, and curb climbing (5.5") ability make it a versatile vehicle equally adept in the shopping mall, on firm surface wilderness trails, or in the close quarters of a restaurant or home kitchen. Navigator I is a blended hybrid drawine elements from both scooters and wheelchairs, to meet desired features requested by long term scooter users. It does this while still maintaining the three-wheel scooter configuration with manual steering and anti-tip wheels adjacent to the single steering wheel. Navigator I is an clectronically controlled motorized 3-wheeled vehicle employing a rear single wheel remotely steerable motor drive system (11.5" tire). It employs a 24 Volt DC permanent magnet motor powered by two 12 Volt scaled lead acid deep cycle batteries. The rigid Front Frame Assembly holds the two batteries, mounts the two front 16" diameter wheels, the two front hand controlled parking brakes, the swing up front foot rests, the electronic motor controller, and the steering arm with handle incorporating the 6-position variable speed-control. The Rear Frame Assembly is made up of the rear motor drive, the swing out Anti-tip wheels, the rear bearing block assembly and pivot wheel assembly. The Front and Rear Frame Assemblies are connected together by two semi-rigid Torsional Elements™ (relatively rigid to a vertical load, but allowing limited rotation), which also support the scat block mounting assembly. The Torsional Elements™ allow limited twist (similar to the Articulation Beam in the Pride Jazzy, K945936) to occur between the Front and Rear Frame Assemblics up to 5° of rotation, at which point one Anti-tip wheel with the ground. This greatly enhances side to side stability when driving Navigator I over rough terrain, since Navigator I is smothly transformed from three wheels to four wheels with ground contact on all four wheels.
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