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510(k) Data Aggregation

    K Number
    K250729
    Device Name
    Power Wheelchair (MOB1107)
    Manufacturer
    Vive Health LLC
    Date Cleared
    2025-07-02

    (113 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251285
    Device Name
    Electric Wheelchair (HG-630)
    Manufacturer
    Zhejiang Automwheel Tech Co., Ltd.
    Date Cleared
    2025-07-02

    (68 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251606
    Device Name
    Power Wheelchair (D26)
    Manufacturer
    Anhui JBH Medical Apparatus Co., Ltd.
    Date Cleared
    2025-06-25

    (29 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The power wheelchair 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 power wheelchair, model name:D26, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: D26, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
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    K Number
    K251248
    Device Name
    ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)
    Manufacturer
    Jinhua Qidian Vehicle Co. Ltd
    Date Cleared
    2025-06-20

    (58 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    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
    This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The wheelchair can easily fold and unfold for transportation or storage.The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The QDWP-A01 uses lithium batteries as its power source, The QDWP-B02 uses lead acid batteries as its power source.The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of QDWP-A01 is aluminum,the frame of QDWP-B02 is steel. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement. The motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
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    K Number
    K250475
    Device Name
    Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
    Manufacturer
    NINGBO BAICHEN MEDICAL DEVICES CO., LTD
    Date Cleared
    2025-05-27

    (97 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Electric Wheelchair 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 product is intended only carry one person and used as a means of transportation for the old and infirm who have difficulty in moving. The maximum occupant mass is 100kg. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, Battery charger socket), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices. The wheelchair can easily fold and unfold for transportation or storage.
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    K Number
    K250758
    Device Name
    Electric Wheelchair (F309)
    Manufacturer
    CHANGSHU PINGFANG WHEELCHAIR CO., LTD
    Date Cleared
    2025-05-09

    (57 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Electric Wheelchair 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 product is intended only carry one person and used as a means of transportation for the disabled, and sick. The electric wheelchair is classified as class B and the maximum occupant mass is 120kg. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists two Lithium batteries with an off-board battery charger, frame, controller, motors, seat with cushion, back support with cushion, control device (including the battery power indicator, power ON button, power OFF button, horn button, speed indicator, speed-up button, slow-l down button, joystick, charging port), arm supports, two rear wheels, two casters(front wheels), foot support, anti-tip devices, push handle. The wheelchair can easily fold and unfold for transportation or storage.
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    K Number
    K243110
    Device Name
    eFOLDi Navigator Powerchair (STPC-A)
    Manufacturer
    SunTech UK Ltd.
    Date Cleared
    2025-05-08

    (220 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "eFOLDi Navigator Powerchair STPC-A" 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 eFOLDi Navigator Powerchair STPC-A 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 wheelchair has two front wheels, two rear wheels, two electric motors with electromagnetic brake, and one rechargeable Lithium-Ion batteries with an off-board charger. The movement of the wheelchair is controlled by the joystick controller or attendant control. When attendant control is in use, the wheelchair no longer responds to the joystick controller. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually. The wheelchair only can be operated on the flat road for both outdoor and indoor use, hospital, senior center, family or similar circumstances use only. The Powerchair only can be operated on the flat road or slopes less than 6 degrees. The Powerchair is foldable. The Powerchair has a physical dimension of 108 (depth) x 59 (width) x 89 (height) cm, with the seat itself has a dimension of 35 (depth) x 45 (width) x 50 (height) cm. The footrest is 10 cm in height. The Powerchair is foldable, and the folded dimension is 34 (Long) x 59 (width) x 89 (height) cm. The device has a weight capacity of 120 kilograms, and weighs 14 kilograms with battery (12 kilograms without battery). The color is black. The Powerchair consists of four wheels, a magnesium alloy mechanical main frame, seat, handle, and 100% polyester flame retardant cloth for upholstery that is ignition resistant. The Powerchair uses solid Polyurethane wheels and the front wheel has a diameter of 20 cm (8 inch) and the back wheel has a diameter of 30 cm (11.5 inch). Both front wheel and back wheels use solid tires. The Powerchair has two motors of 24V and 180 Watt, which allows a maximum speed of 5.6 kilometers per hour, and maximum travel range of 13 kilometers. It brakes in the form of electromagnetic force to apply mechanical resistance to the back wheels to force stop. The wheelchair is equipped with anti-tipper device.
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    K Number
    K250158
    Device Name
    Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)
    Manufacturer
    Zhe jiang Cleisman Industry and Trade Co.,LTD
    Date Cleared
    2025-04-28

    (97 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    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
    This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame's material of model ZH-W001 and ZH-W002 is aluminium alloy,the model ZH-W003 is carbon steel. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are PU tires. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement. The DC motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
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    K Number
    K250748
    Device Name
    KLAXON (TWIST); KLAXON (TWIST R)
    Manufacturer
    KLAXON-MOBILITY GmbH
    Date Cleared
    2025-04-11

    (30 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TWIST and TWIST R are add-on drive accessories for wheelchairs. The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
    Device Description
    The device is an add on accessory for manual wheelchairs. ### 1. TWIST TWIST device is meant to be added to the wheelchair in 5 different combinations of position and control: 1. Front mounted without handlebar, driven by the wheelchair occupant 2. Front mounted without handlebar, driven by the attendant 3. Front mounted position with handlebar, driven by the wheelchair occupant 4. Rear mounted without handlebar, driven by the wheelchair occupant 5. Rear mounted without handlebar, driven by the attendant Coupling the TWIST device in front position to the wheelchair raises the front castors off the ground. The single wheel of the "traction unit" is then used for steering. ### 2. VARIATION TWIST R VARIATION TWIST R device is meant to be added to the wheelchair in 1 only position (rear) and 2 ways of control 1. Rear mounted without handlebar, driven by the wheelchair occupant 2. Rear mounted without handlebar, driven by the attendant
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    K Number
    K250366
    Device Name
    Electric Wheelchair (LW01301A07)
    Manufacturer
    Anhui Longway Medical Technology Co., LTD
    Date Cleared
    2025-04-08

    (57 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Product Code :

    ITI

    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
    This Electric Wheelchair, model: LW01301A07, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger. The device is powered by Li-ion Battery pack with 17.6 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
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