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510(k) Data Aggregation
(184 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Electric Scooter, has a base with metal frame, two front wheels, two rear wheels, a seat, a LCD Display, electric motor, electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the control lever, speed control turn "speed" Knob. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat surface. The device can be folded from front to back. Till height and armrest width is adjustable.
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(184 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Electric Scooter, has a base with metal frame, two front wheels, two rear wheels, a seat, a LCD Display, electric motor, electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the control lever, speed control turn "speed" Knob. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat surface. The device can be folded from up to down by manual.
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(191 days)
The electric scooter is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The electric scooter is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Mobility Scooter, Model DDF100, consists with two front wheels, two rear wheels, two rear anti-tip wheels, one seat system with one back support and two arm supports, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, one rechargeable Lithium-Ion battery and one off-board charger.
The movement of the wheelchair is controlled by the speed lever and steering column. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake can be manually adjusted to free wheel mode. The scooter only can be operated on the flat road.
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(109 days)
It is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Electric Scooter (model: S202572J, S2060, M2089, S2050) is an indoor electric scooter that is battery operated.
The Electric Scooter (Model: S202572J, S2060, M2089, S2050) is with 125 kg weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable frames (S202572J: carbon fiber frame, S2060, M2089, S2050: aluminum alloy frame), a sealed trans-axle motors drive system, electromagnetic braking system, electric motor controller and a Li-ion batteries with an off-board battery charger. It is powered by 25.2 V/10 AH rechargeable Lithium batteries with 15 km which maximum speed up-to 6 km/hr. The direction control lever to control the direction of the Electric Scooter.
For model S202572J, when pushing the right acceleration push rod forward with the right finger, the electric scooter moves forward, when pushing the left acceleration push rod forward with the left finger, the electric scooter moves backward, the electromagnetic brake will be actuated when the acceleration push rod is released and the electric scooter will stop. It consists of four parts which are chair part, control part, folding part and drive part. Overall, it mainly has a basic carbon fiber frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a control panel, an electric motor, an electromagnetic brake, two armrests and a Lithium battery with an off-board charger. The control panel has eight buttons, the acceleration push rod, a display screen showing the device status and NFC unlocking sensing area.
For model S2060, when pushing the right acceleration push rod backward with the right finger, the electric scooter moves forward, when pushing the left acceleration push rod backward with the left finger, the electric scooter moves backward, the electromagnetic brake will be actuated when the acceleration push rod is released and the electric scooter will stop. It consists of four parts which are chair part, control part, folding part and drive part. Overall, it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a control panel, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The control panel has five buttons, the acceleration push rod, a display screen showing the device status and NFC unlocking sensing area.
For model M2089, when pushing the right acceleration push rod forward with the right finger, the electric scooter moves forward, when pushing the left acceleration push rod forward with the left finger, the electric scooter moves backward, the electromagnetic brake will be actuated when the acceleration push rod is released and the electric scooter will stop. It consists of four parts which are chair part, control part, folding part and drive part. Overall, it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, four backline anti-tip wheels, a seat, a control panel, an electric motor, an electromagnetic brake, two armrests and a Lithium battery with an off-board charger. The control panel has five buttons, the acceleration push rod, a display screen showing the device status.
For model S2050, when pushing the right acceleration push rod forward with the right finger, the electric scooter moves forward, when pushing the left acceleration push rod forward with the left finger, the electric scooter moves backward, the electromagnetic brake will be actuated when the acceleration push rod is released and the electric scooter will stop. It consists of four parts which are chair part, control part, folding part and drive part. Overall, it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a control panel, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The control panel has a battery level indication area, a speed control knob, a horn button, a power control keyhole and the acceleration push rod.
The model S202572J, S2060, M2089, S2050 are identical in circuit structure and key components (such as battery, charger, controller, motor) except for some differences shown in the appearance and function. About appearance of the four models, the model S202572J and model S2060 are different in the material of the frame, the control panel, the size of tires, the overall size and the backrest shape. The model S2050 and model S2060 are different in the shape of seat bracket, the control panel and the backrest shape. The model M2089 and model S2060 are different in the shape of seat bracket, the pedal, the overall size and the backrest shape. The model S2060, S2050 have no armrest, while the model S202572J, M2089 have two armrests.
About function of the four models, the folding method of model M2089 are different from the model S202572J, S2060, S2050. The tiller height of model S202572J, S2060, S2050 is adjustable, while the tiller height of model M2089 is non-adjustable.
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(167 days)
It is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Electric Scooter (M2085, S2091)". This document does not contain information about acceptance criteria or a study proving that a device (specifically an AI/ML medical device, which is what your query implies) meets those criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text. The document discusses regulatory approval for an electric scooter, not an AI software or a clinical study's findings.
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(183 days)
I is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Electric Scooter (Model: M2020)
The provided text is an FDA 510(k) clearance letter for an electric scooter (Model: M2020) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML-driven medical device.
The document discusses:
- The FDA's determination of substantial equivalence for an electric scooter.
- Regulatory requirements for the device (e.g., registration, listing, labeling, good manufacturing practices).
- The product code (INI) and regulation number (21 CFR 890.3800), which pertain to "Motorized Three-Wheeled Vehicle."
- Indications for Use of the electric scooter: "It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position."
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided input does not describe such a device or study.
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(60 days)
I is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Electric Scooter (Model: S3312)
I am sorry, but the provided text is a 510(k) clearance letter for an electric scooter and does not contain information about the acceptance criteria or a study proving device performance for a medical device that would have these types of criteria and studies associated with it.
Therefore, I cannot extract the requested information.
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(290 days)
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