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510(k) Data Aggregation

    K Number
    K252813

    Validate with FDA (Live)

    Date Cleared
    2026-03-17

    (194 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    China

    Re: K252813
    Trade/Device Name: Electrical Scooter (SM4226)
    Regulation Number: 21 CFR 890.3800
    ** Electrical Scooter
    Classification name: Motorized Three-Wheeled Vehicle
    Class II, 21 CFR 890.3800

    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

    Electrical Scooter, SM4226, is for indoor or outdoor uses, and it is powered by two 12 Ah sealed Lead-acid batteries with an off-board charger and configured with 4 PU solid wheels, 2 anti-tip wheels, a seat, a turning tiller, aluminum alloy main frame and a control panel.

    SM4226 is driven by two PU solid rear wheels (7.48" x 2.16") and steered by two PU solid front wheels (7.48" x 2.16%). The user can control the turning tiller to control the front wheels to steer the scooter's direction. The movement of the scooter is controlled by the rider who operates the throttle lever to drive forward or backward, speed adjustment knob and handles on the turning tiller. Release the throttle lever completely and the electromagnetic brake installed in the motor will be activated automatically, and the scooter will stop. There are two anti-tip wheels to prevent the tipping hazard.

    The maximum weight capacity is 297 lbs. (135 kg). Its maximum forward speed is 4 mph (6.4 km/h), and its maximum safe climbing incline angle is 6 degrees. The cruising range per charge is 6.875 miles (11 km). There is a storage basket affixed to the turning tiller.

    The following surfaces are recommended NOT to operate on:

    • Sand surface
    • Wet or icy surface
    • Road maintenance hole metal cover
    • Avoid going up multiple steps.
    • Avoid using escalators. Use the elevator.
    • Too steep incline over 6 degrees.
    • Obstacle climbing ability over 1.96"/ 50 mm
    • Ground clearance below 1.96"/50 mm
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    K Number
    K253936

    Validate with FDA (Live)

    Date Cleared
    2026-03-12

    (93 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    K253936**
    Trade/Device Name: Power Mobility Scooter (MJMA01, MJMA02)
    Regulation Number: 21 CFR 890.3800
    vehicle

    Regulatory Information
    Classification: Class II
    Product code: INI
    Regulation Number: 890.3800

    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 is a battery powered four wheeled vehicle that provides mobility to a disabled or elderly person limited to a seated position. It is primarily for indoor use and restricted outdoor use on pavements or paved footpaths. The maximum loading weight is 120kg. It consists of one Lithium-ion battery with an off-board battery charger, frame, controllers, motors, seat, back support, control device (including power switch & speed adjustment, horn switch, throttle & brake, handlebars, head lamp switch, real-time speed, power), two rear wheels, two front wheels, foot support (pedal), and anti-tip devices. The battery can be dismantled for transportation and users can easily assemble the parts without tools. Model MJMA01 is not equipped with armrests, while MJMA02 is equipped with armrests.

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    K Number
    K253631

    Validate with FDA (Live)

    Date Cleared
    2026-02-23

    (96 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    K253631**
    Trade/Device Name: Mobility Scooter (CL-Q3, CL-Q4)
    Regulation Number: 21 CFR 890.3800
    Regulation Name:** Motorized Three-Wheeled Vehicle
    Regulation Class: II
    Regulation Number: 21CFR 890.3800
    |
    | Device classification name | Class II | Class II | Same |
    | Classification regulations | 21 CFR 890.3800
    | 21 CFR 890.3800 | Same |
    | Product code | INI | INI | Same |
    | Indication for use | It is a motor

    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

    This mobility 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, has a base with two front wheels, two rear wheels, two support wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable battery with an off-board charger, a key switch. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. 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 can only be operated on the flat road.

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    K Number
    K253643

    Validate with FDA (Live)

    Date Cleared
    2026-02-18

    (91 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Shanghai,
    China

    Re: K253643
    Trade/Device Name: Mobility Scooter (S3)
    Regulation Number: 21 CFR 890.3800

    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

    Not Found

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    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
    Why did this record match?
    510k Summary Text (Full-text Search) :

    China

    Re: K252349
    Trade/Device Name: Electric Scooter (Mojo-T330)
    Regulation Number: 21 CFR 890.3800
    Electric Scooter
    Model: Mojo-T330
    Classification: II
    Product Code: INI
    Regulation: 890.3800
    Mojo-T330 | PMS101 | NA |
    | Product Code | INI | INI | Same |
    | Device Classification Regulation | 890.3800
    | 890.3800 | Same |
    | Indications for use | The device is intended for medical purposes to provide mobility

    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
    Why did this record match?
    510k Summary Text (Full-text Search) :

    China

    Re: K252347
    Trade/Device Name: Electric Scooter (Mojo-T580)
    Regulation Number: 21 CFR 890.3800
    Electric Scooter
    Model: Mojo-T580
    Classification: II
    Product Code: INI
    Regulation: 890.3800
    Mojo-T580 | PMS101 | NA |
    | Product Code | INI | INI | Same |
    | Device Classification Regulation | 890.3800
    | 890.3800 | Same |
    | Indications for use | The device is intended for medical purposes to provide mobility

    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
    Why did this record match?
    510k Summary Text (Full-text Search) :

    , China

    Re: K252275
    Trade/Device Name: Electric Scooter (DDF100)
    Regulation Number: 21 CFR 890.3800
    three-wheeled vehicle |
    | Classification Name | Vehicle, Motorized 3-Wheeled |
    | Regulation Number | 890.3800

    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
    Why did this record match?
    510k Summary Text (Full-text Search) :

    mobility scooter (Air Traveller); mobility scooter (Air Traveller 2.0)
    Regulation Number: 21 CFR 890.3800
    Mobility Scooter
    Model: Air Classic,Air Traveller,Air Traveller2.0
    Classification regulations:21 CFR 890.3800
    Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT),K231472
    Classification regulations:21 CFR 890.3800
    |
    | Device classification name | Class II | Class II | Same |
    | Classification regulations | 21 CFR 890.3800
    | 21 CFR 890.3800 | Same |
    | Product code | INI | INI | Same |
    | Indication for use | It is a motor

    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
    Why did this record match?
    510k Summary Text (Full-text Search) :

    China

    Re: K252817
    Trade/Device Name: Mobility Scooter (BC-MS310)
    Regulation Number: 21 CFR 890.3800
    China

    Re: K252817
    Trade/Device Name: Mobility Scooter (BC-MS310)
    Regulation Number: 21 CFR 890.3800
    three-wheeled vehicle |
    | Classification Name | Vehicle, Motorized 3-Wheeled |
    | Regulation Number | 890.3800

    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
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Trade/Device Name: Electric Scooter (S202572J, S2060, M2089, S2050)
    Regulation Number: 21 CFR 890.3800
    Physical Medicine
    Product Code: INI
    Regulation Class: 2
    Regulation Number: 21 CFR 890.3800
    Physical Medicine
    Product Code: INI
    Regulation Class: 2
    Regulation Number: 21 CFR 890.3800
    Scooter | Solax Electric Scooter | |
    | Product Code | INI | INI | Same |
    | Regulation Number | 21 CFR 890.3800
    | 21 CFR 890.3800 | Same |
    | Regulation Description | Motorized three-wheeled vehicle. | Motorized three-wheeled

    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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