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510(k) Data Aggregation
K Number
K954378Device Name
FORMULA IV ELECTRIC MOBILITY VEHICLE
Manufacturer
AEROTEK
Date Cleared
1996-07-25
(310 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
AEROTEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Formula IV is a method of transportation used by people with limited mobility. It is designed for veople who cannot walk a great distance because of age, arthritis, breathing problems, etc. It may also be used by the disabled though it not intended as a person's sole means of mobility.
Device Description
The Formula IV is comparable with other three and four wheel scooters currently on the market such as those built by Jubilee Scooters Inc, Ortho-Kinetics, and Pride Health Care to name a few. The vehicle is approximately the same size as any other scooter. It is operated by two 12 volt batteries, which are located under the seat. The motor is a 24 volt and will be shielded to prevent any interference by microwaves from cellular phones, etc. The vehicle's speed control and electronics are similar to any other mobility vehicle presently on the market.
The Formula IV is safer than the competition because it utilizes four wheel steering which gives it exceptional maneuverability and stability. It also has a semi enclosed fibreglass body which acts as leg protection and concealed storage.
The seat is a fibreglass molded design with thick padding for comfort. The seat swivels to either side to enable the driver to get in and out easily. When the seat is swivelled a locking mechanism prevents it from moving while the person is sitting down. Also the vehicle brake is engaged when the seat is swivelled so that if the person touches the accelerator paddle the vehicle will not move.
The Formula IV is manually operated by a small hand paddle on the steering wheel which when pushed forward will advance the vehicle and when pushed down will reverse the vehicle. This accelerator paddle was designed for people with manual dexterity problems. It can be easily operated with the thumb, forefinger or the palm of the hand. Other mobility vehicles are operated by squeezing a trigger mechanism which is difficult for someone lacking manual dexterity. The brake is automatically activated when the hand is lifted off the accelerator paddle.
Horn, dual headlights. cane holder, flashing rear safety light are all standard safety features on all vehicles. The rear safety light is positioned high on the back of the seat for optimum visibility to traffic or pedestrians following the vehicle. The Formula IV was designed to be safe.
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