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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    Anhui JBH Medical Apparatus Co., Ltd

    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
    K241374
    Device Name
    Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)
    Manufacturer
    Anhui JBH Medical Apparatus Co., Ltd
    Date Cleared
    2025-02-28

    (289 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui JBH Medical Apparatus Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
    Device Description
    The S002, S004, S005, S006, S007, S008, S009 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant. Main Components: Main frame, Backrest, Seat cushion, handgrip, front wheel, rear wheel, hand rim, crossbar, footrests, brake, Anti-tipper, Seat belt. The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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    K Number
    K242448
    Device Name
    Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
    Manufacturer
    Anhui JBH Medical Apparatus Co., Ltd.
    Date Cleared
    2025-01-02

    (139 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui JBH Medical Apparatus Co., Ltd

    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: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, is an indoor/outdoor, foldable, battery-operated 2-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-lon 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: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, 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
    K242468
    Device Name
    Power Wheelchair (D10, D12, D15, D17, D20, D37)
    Manufacturer
    Anhui JBH Medical Apparatus Co., Ltd.
    Date Cleared
    2024-12-31

    (133 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui JBH Medical Apparatus Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The power wheelchair 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 power wheelchair, model name: D10, D12, D15, D17, D20, D37, 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-lon 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: D10, D12, D15, D17, D20, D37, 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 (Model D10, D12, D15, D17, D20, D37) can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange. The D17 power wheelchair has an additional headrest and its seat unit can be adjusted by a remote control key to a largest angle of 30°.
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    K Number
    K242252
    Device Name
    Power Wheelchair
    Manufacturer
    Anhui JBH Medical Apparatus Co., Ltd.
    Date Cleared
    2024-12-27

    (149 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui JBH Medical Apparatus Co., Ltd

    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: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, 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-lon 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: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, 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 wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.
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    K Number
    K241854
    Device Name
    Power Wheelchair
    Manufacturer
    Anhui JBH Medical Apparatus Co., Ltd.
    Date Cleared
    2024-10-04

    (99 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui JBH Medical Apparatus Co., Ltd

    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 D25 power wheelchair is a four wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitable for disabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The power wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway. The wheelchair (Model D25) has a base with aluminum alloy frame, two front wheels, two rear wheels, a seat, an adjustable steering column, a tiller console, two electric motors, an electromagnetic brake, 1 rechargeable Lithium-lon Battery with an off-board charger. The movement of the wheelchair 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 wheelchair is not in use and the brake cannot be used manually.
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    K Number
    K212092
    Device Name
    Portable Folding Electric Wheelchair (Model: DC01)
    Manufacturer
    Anhui JBH Medical Apparatus Co., Ltd
    Date Cleared
    2022-05-06

    (304 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui JBH Medical Apparatus Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wheelchair (Model: DC01) 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 device is Electric Wheelchair, model no. is DC01. An electric wheelchair is a four-wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The electric wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway. The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, electromagnetic brake system, battery box, controller and battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back cushion. The device is powered by Li-ion Battery pack (24V 6Ah, 144Wh) with 20 Km (12.5 miles) 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 will return back to the central position and the wheelchair will be automatically stopped soon due to automatic intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
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    K Number
    K210302
    Device Name
    Disposable Medical mask
    Manufacturer
    Anhui JBH Medical Apparatus Co., Ltd.
    Date Cleared
    2021-05-14

    (100 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui JBH Medical Apparatus Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The Disposable Medical Masks are single use, three-layer, flat –folded masks with ear strings or ties and nose clip. The two models are exact same except the loop versus tie on design. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The three layers fabric are held together by ultrasonic welding. The earloops/tie-on ties are held in place over the users' mouth and nose by two strings welded to the facemask. The earloops are made of 19cm spandex and the tie-on ties are made of 90cm spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
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