(310 days)
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No
The description focuses on mechanical and basic electronic components typical of mobility scooters, with no mention of AI or ML capabilities.
No
The device is described as a method of transportation for people with limited mobility, comparable to other mobility scooters on the market. It assists with mobility but does not treat a disease or condition or restore function.
No
The device description indicates that the Formula IV is a method of transportation, specifically a scooter, for people with limited mobility. It describes its physical characteristics, operation, and safety features. There is no mention of it being used to diagnose diseases or conditions.
No
The device description clearly details a physical vehicle with batteries, a motor, wheels, a body, and a seat, indicating it is a hardware device, not software-only.
Based on the provided text, the Formula IV is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Formula IV is a "method of transportation used by people with limited mobility." This describes a physical mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a vehicle with wheels, batteries, a motor, a seat, and controls for movement. This aligns with a mobility scooter, not an IVD device which would typically involve analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic information
- Laboratory use
Therefore, the Formula IV is a mobility device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
891T1
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.3800 Motorized three-wheeled vehicle.
(a)
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.(b)
Classification. Class II (performance standards).
0
11 25 199
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 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.
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.