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510(k) Data Aggregation
K Number
K240563Device Name
Power Wheelchair (JJW-6001)
Manufacturer
ZheJiang J&J Mobility Co., Ltd
Date Cleared
2024-10-08
(222 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
ZheJiang J&J Mobility Co
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 Power Wheelchair, model: JJW-6001, 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 16 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 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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K Number
K240255Device Name
Electric Wheelchair (JLE-W01A-2023)
Manufacturer
Zhejiang Jianrui Technology Company Limited
Date Cleared
2024-08-07
(189 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Jianrui Technology Company Limited
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 (JLE-W01A-2023), 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, charger and anti-tip wheels.
The device is powered by Li-ion Battery pack with 27.5 Km range, which can be recharged by an offboard 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.
Anti-tip wheel is a safety device to prevent the wheelchair from turning over when driving on the slope. When the operator needs to use the subject electric wheelchair, he must pull down the anti-tip wheels.
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K Number
K132257Device Name
MANUAL WHEELCHAIR
Manufacturer
ZHEJIANG JIAFENG ELECTRICAL & MECHANIAL CO., LTD
Date Cleared
2014-02-13
(209 days)
Product Code
IOR, MAN
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
ZHEJIANG JIAFENG ELECTRICAL & MECHANIAL CO
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. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater than 8 degrees.
Device Description
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.
The Manual Wheelchairs Model SY 100-MA02 (02A & 02B) and Model SY 100-MA06 (or other clients private labeling) are user propelled, manually operated folding wheelchairs that are indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater than 8 degrees. Each consists of four wheels, a mechanical steel frame and nylon upholstery that is ignition resistant. The device is designed to be lightweight and foldable, and can be dissembled. In both models, both rear and caster wheels use solid tires.
The model SY100-MA02 has two sub-models (02A & 02B) which both has a physical dimension of 1025 (depth) x 661 (width) x 920 (height) mm, with the seat itself has a dimension of 408 (depth) x 440 (width) x 455 (height) mm. The device has a weight capacity of 130 kilograms.
Sub-model MA02A uses hard plastic back wheels and weighs approximately 16.5 kilograms. Sub-model MA02B uses wired steel wheels and weighs 13.8 kilograms. Both sub-models are dark green in color.
Model SY100-MA06 has a physical dimension of 1026 (depth) x 651 (width) x 860 (height) mm. with the seat itself has a dimension of 394 (depth) x 374 (width) x 482 (height) mm, and a weight capacity of 100 kilograms, and weighs approximately 15.2 kilograms.
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