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510(k) Data Aggregation

    K Number
    K251638
    Device Name
    Mobility Scooter (MS160C)
    Manufacturer
    Suzhou Master Machinery Manufacturing Co., Ltd.
    Date Cleared
    2025-07-22

    (54 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243102
    Device Name
    Mobility Scooter (JT10)
    Manufacturer
    Jiangxi Jiangte Electric Vehicle Co., Ltd.
    Date Cleared
    2025-06-18

    (261 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mobility Scooter (Model: JT10) 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, Model JT10 is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with steel frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, electric motor, electromagnetic brake, 2 rechargeable Lead-acid batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed knob 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 only can be operated on the flat road.
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    K Number
    K250533
    Device Name
    Magnesium alloy scooter (RS100)
    Manufacturer
    Taizhou Reach Technology Co., Ltd
    Date Cleared
    2025-05-14

    (79 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    RS100 is a Mobility Scooter which provides mobility to a disabled or elderly person limited to a seated position. The Mobility Scooter is classified in the Class B and the maximum loading weight is 125kg. The scooter is a battery powered three-wheeled vehicle. It consists Lithium-ion battery with an off-board battery charger, frame, controllers, motor, seat, back support, arm supports, control panel (including speed knob, battery gauge, power key switch, horn button, throttle control lever, charger port) two rear wheels, one front wheel, foot support. For convenience of transportation and reduction of possible damage, the battery and arm supports can be dismantled and separately packaged. Users can also easily assemble these parts without use of the tools.
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    K Number
    K242975
    Device Name
    Mobility Scooter (Model X-01, X-02)
    Manufacturer
    Wuyi Aichi Industry & Trade Co., Ltd.
    Date Cleared
    2025-05-07

    (223 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended / indications for use for the FreeStyle Libre 3 system are as follows: * The FreeStyle Libre 3 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real-time alarms capability indicated for the management of diabetes in persons aged 4 years and older. * It is intended to replace blood glucose testing for diabetes treatment decisions unless otherwise indicated. * The System performs a scan every minute to measure interstitial fluid glucose concentrations.
    Device Description
    Google Wifi point and AC2200 router with Ethernet port and USB-C port
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    K Number
    K250027
    Device Name
    Powered Mobility Scooter
    Manufacturer
    Intradin (Shanghai) Machinery Co., Ltd
    Date Cleared
    2025-02-21

    (46 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powered Mobility scooteris intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    Powered Mobility Scooter
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    K Number
    K242982
    Device Name
    Mobility Scooter (MS160A)
    Manufacturer
    Suzhou Master Machinery Manufacturing Co., Ltd.
    Date Cleared
    2025-01-31

    (127 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 subject device, Model MS160A scooter is mainly battery-powered and driven by a DC motor, with the speed adjusted by a user-controlled panel. The motor is driven, and the speed is adjusted by a user-controlled panel and speed knob. The scooter consists of two folding armrests, a seat cushion, a folding frame, two front wheels, two rear drive wheels with a motor/electromagnetic brake assembly, a rechargeable lithium-ion battery, an off-board battery charger, a control panel, and a motor controller. The MS160A scooter is designed to provide mobility for people limited to those who walk unchanged or for the elderly. Folding design: Pull out the seat and backrest fixing pins, push the backrest forward, the seat and backrest fold into each other, release the handlebar locking knob, push the handlebar backward, the handlebar folds down, the whole scooter is folded. Control panel: Includes speed knob, battery gauge, power key switch, horn button, throttle control lever, headlight switch, charger port, fuse. Wheel and frame connection method: the motor is connected to the differential, the differential is connected to the frame, the wheels are mounted on both ends of the differential, the motor rotates with the differential, thus driving the scooter. Frame design: 1) The frame of MS160A is aluminum alloy. 2) The folding mechanism is operated in two ways: a. In the non-riding state, pull out the seat fixing pin, push the backrest forward, the seat and backrest can be folded. b. Loosen the handlebar locking knob, push the handlebar forward, the handlebar will fold down. The front wheels of the scooter are 7 inches and the rear wheels are 10 inches. The motor of the scooter is ST-62D24-120W; the lithium-ion battery is 25.55V 10.4AH; the charger is 24V/2A. Max. loading cannot be over than 125kg. The maximum distance travelled with a fully charged battery is 8.2km and the maximum forward speed is 1.8m/s. Braking time is about 2 seconds, braking distance is ≤1.5 meters.
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    K Number
    K242714
    Device Name
    Mobility Scooter (S-01); Mobility Scooter (S-02)
    Manufacturer
    Zhejiang Seedream Medical Equipment Co., Ltd.
    Date Cleared
    2025-01-23

    (135 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    K240590
    Device Name
    Electrical Scooter, WT-T4SU
    Manufacturer
    W'u's Tech Co., Ltd.
    Date Cleared
    2025-01-08

    (313 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    WT-T4SU is for indoor or outdoor uses, and it is Lithium-ion battery powered and configured with four solid wheels, a seat, a turning tiller, and a control panel. WT-T4SU is driven by two PU solid rear wheels (7.28" x 1.96") and steered by two PU solid castors (7.28" x 1.96"). The user can control the turning tiller to control the castors to steer the scooter's direction. Control panel has 3 functions of battery level indication, speed lever and forward/reverse selector. The user can pull the speed lever to drive forward or drive backward. Release the speed lever completely and the electromagnetic brake in the motor will be activated automatically, and the scooter will stop. The maximum weight capacity of WT-T4SU is 264 lbs. (120 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 is 6.61 miles (10.58 km).
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    K Number
    K242139
    Device Name
    Mobility Scooter (YL-09B, YL-07)
    Manufacturer
    Yongkang Yile Vehicle Co.,Ltd
    Date Cleared
    2025-01-06

    (168 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Ask a Question
    K Number
    K242760
    Device Name
    WHILL Model R
    Manufacturer
    Whill, Inc.
    Date Cleared
    2025-01-06

    (116 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Product Code :

    INI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model R 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
    WHILL Model R is an indoor/outdoor electric scooter that is intended as a mobility aid for elderly persons or persons with reduced mobility. Providing Bluetooth-based radio communications functionalities. Model R is available in two variants, the 3-wheel model and the 4-wheel model. The 3-wheel scooter has a base with metal alloy frame, one front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, 2 electric motors, 2 electromagnetic brakes, a rechargeable lithium-ion battery with an off-board charger. The 4-wheel scooter has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, 2 electric motors, 2 electromagnetic brakes, a rechargeable lithium-ion battery with an off-board charger. The only difference between 3-wheel model and 4-wheel model is front drive-base component. The 3-wheel model has a single front tire, while the 4-wheel model has two front tires. Besides this difference in mechanical design, other parts of the device are identical across the two models. Customers can choose a model depending on their preferences and use case. Model R has a removable lithium-ion battery, a swivel 17-inch-wide seat with two armrests and front and rear LED lights. The battery may be charged either when installed within the device or when removed. Some components are adjustable to provide user with a comfortable riding position. The inner width and the height of the armrests are adjustable in 3 positions. The seat position from the tiller is adjustable in 4 positions. The seat height is adjustable in 2 positions and the tiller angle is also adjustable. A lap belt is equipped for posture support and for safety. As with all conventional powered scooters, to drive the Model R, the user sits in the seat and grips the tiller handle around the controller unit which is positioned in front of the user. While gripping the tiller handle, the user uses their fingers to pull the right side of the throttle control lever gently to drive the device forward. The degree at which the throttle control lever is pulled is positively proportional to the speed of the device. When the throttle control lever returns to its original position after the user releases it, the device decelerates and comes to a stop. When the user uses their fingers to pull on the left side of the lever, the device drives backwards. To move to the left, the user turns the tiller handle to the left, and, to the right, the user turns the tiller handle to the right. Model R has Bluetooth-based radio communications capabilities. The user can power on Model R with a physical key, a Bluetooth smart key fob or with a dedicated smartphone app. The user can select speed profiles, turn off and on the front LED light and sound the audible warning device by operating the controller unit. User can disassemble Model R into four components, i.e. drive base, main body, seat base assembly and battery, without the use of tools when loading into a car for transportation. The device supports a maximum weight of 147 kg (325 lbs.), including the weight of the occupant and any carried items. The 3-wheel model has a theoretical continuous driving range of 18.7 km (11.6 miles) while the 4-wheel model has a theoretical continuous driving range of 17.2 km (10.7 miles).
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