FORMULA IV ELECTRIC MOBILITY VEHICLE

K954378 · Aerotek · INI · Jul 25, 1996 · Physical Medicine

Device Facts

• Record ID: K954378
• Device Name: FORMULA IV ELECTRIC MOBILITY VEHICLE
• Applicant: Aerotek
• Product Code: INI · Physical Medicine
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The Formula IV is a method of transportation used by people with limited mobility. It is designed for people 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 Story

Electric mobility scooter; provides transportation for individuals with limited mobility. Input: user operation via hand-actuated accelerator paddle on steering wheel. Operation: 24V motor powered by dual 12V batteries; four-wheel steering for maneuverability/stability; semi-enclosed fiberglass body for leg protection/storage. Output: vehicle propulsion. Safety features: automatic braking upon release of accelerator; seat-swivel locking mechanism; brake engagement during seat swivel; horn; dual headlights; rear safety light. Operated by user in various settings; assists with mobility; reduces physical strain associated with walking.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Powered mobility scooter; 24V motor; dual 12V battery power source; fiberglass molded seat and body; four-wheel steering mechanism; electromagnetic/automatic braking system; shielded electronics for microwave interference protection.

Indications for Use

Indicated for individuals with limited mobility due to age, arthritis, respiratory conditions, or disability who are unable to walk long distances; not intended as a sole means of mobility.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Reference Devices

• Jubilee Scooters Inc scooters
• Ortho-Kinetics scooters
• Pride Health Care scooters

Submission Summary (Full Text)

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K954378

JUL 25 1995

510 K SUMMARY

September 14, 1995

Trade name - Formula IV
Common Name - Electric Mobility Vehicle/ Scooter
Classification Name - Powered Wheelchair
Classification Number - 891T1
Class II

The Formula IV is a method of transportation used by people with limited mobility. It is designed for people 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.

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.