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510(k) Data Aggregation

    K Number
    K252349

    Validate with FDA (Live)

    Date Cleared
    2026-01-29

    (184 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    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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    K Number
    K252347

    Validate with FDA (Live)

    Date Cleared
    2026-01-29

    (184 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    18 - 65
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    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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    K Number
    K252275

    Validate with FDA (Live)

    Date Cleared
    2026-01-29

    (191 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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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    K Number
    K253075

    Validate with FDA (Live)

    Date Cleared
    2026-01-09

    (108 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    The Mobility Scooter(Air Classic, Air Traveller, and Air Traveller 2.0) feature a base with an aluminum frame and an ABS body shell. They come equipped with one or two front wheels, two rear wheels, two armrests, a seat, a control panel, direction handles, electrical machinery, an electromagnetic brake, and rechargeable lithium-ion batteries with an off-board charger.The movement of the scooter is controlled by control panel and direction handles.

    The device is installed with an electromagnetic brake.Seat and handlebar can be folded.The maximum load capacity is 120KG.

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    K Number
    K252817

    Validate with FDA (Live)

    Date Cleared
    2026-01-02

    (120 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is 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.

    Device Description

    The proposed Mobility Scooter (BC-MS310) provide transport for the disabled and the elderly and to be used both indoors and outdoors. The maximum loading weight is 100kg.

    The proposed scooter mainly consists of aluminum alloy frame, two front wheels, two rear wheels, a seat, a tiller console, pedal, a electric motor and one rechargeable Lithium battery with an off-board charger.

    The device is powered by Li-ion battery, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use. Alternatively, the scooter can be charged directly through the tiller port on the control panel.

    The patient can pull the right throttle control lever back with the right fingers to move forward the scooter and pull the left throttle control lever back with the left fingers to move backward the scooter. After the throttle control lever is released, the scooter will stop. The speed of the scooter could be adjusted according to the forward and backward degrees of the throttle control lever.

    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 road. The device can be folded up from front to back.

    The scooters are designed to be a light and compact, smart mobility scooter. The tiller can be adjusted back and forth according to human comfort. The scooter can be manually folded and unfolded including the frames and seat just in one step. It can be put into the trunk of a small, compact car. The battery is removable.

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    K Number
    K252835

    Validate with FDA (Live)

    Date Cleared
    2025-12-23

    (109 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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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    K Number
    K252588

    Validate with FDA (Live)

    Date Cleared
    2025-12-04

    (111 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is 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.

    Device Description

    The Mobility Scooter (T5) is a motor driven, indoor and outdoor transportation vehicle. It has an overall dimension of 1240mm610mm875mm and a steel frame. It features a foldable tiller, removable battery pack, and disassembles for transport. It has 2 rear wheels, a ground clearance of 20 mm, and a maximum loading capacity of 150kg on level ground. The minimum turn radius is 2175mm, and it is powered by a 24V 350W motor with rear-wheel drive. Braking is handled by an electromagnetic brake. It uses a Li-ion Battery 25.6Vdc 15Ah with a 29.4V/2A charger. The maximum speed is 7.92 km/h, and it can handle a maximum slope of 6°. The travel distance is 18.5 km, with a brake time of less than 1 second and a brake distance of ≤1.3m (horizontal-forward at max speed). The total mass is 54 kg. It is intended for indoor use and restricted outdoor use on pavements or paved footpaths only. It does not have a remote control. The folding mechanism includes a foldable column and a removable basket. The front and rear tire diameters are 9 inches.

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    K Number
    K252590

    Validate with FDA (Live)

    Date Cleared
    2025-11-21

    (98 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Powered Mobility scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    The Powered Mobility Scooter, Model PMS105, GUT177, GCAT047 is mainly composed of frame, two front wheel, two drive wheel, control system, motor and drive device, armrest, backrest, seat cushion, pedal, battery and charger. The traveling speed is controlled by the motor, and the traveling direction is manually controlled by the accompanying personnel or passengers. 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 road. When encountering an obstacle in front, please make a detour to avoid the danger of overturning the scooter. It has a driving range of 9.2 km between charges. It is capable of carrying a driver weighing up to 150kg.

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    K Number
    K252502

    Validate with FDA (Live)

    Date Cleared
    2025-10-06

    (59 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    The Folding mobility scooter, has a base with metal frame, two front wheels, two rear wheels, a seat, a LED Display, electric motor, electromagnetic brake, 1 rechargeable Lithium Battery pack (with 2 batteries) with an off-board charger. The movement of the scooter is controlled by the rider who operates the control lever. 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 road. The device can be folded up from front to back.

    The device has 2 options, with a faucet adjustment or without a faucet adjustment.

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    K Number
    K251799

    Validate with FDA (Live)

    Date Cleared
    2025-09-30

    (110 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is 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.

    Device Description

    Not Found

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