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Found 320 results
510(k) Data Aggregation
(179 days)
Guangdong
China
Re: K253307
Trade/Device Name: Electric wheelchair
Regulation Number: 21 CFR 890.3860
Powered Wheelchair
Regulatory Class: II
Product Code: ITI
Regulation Number: 21 CFR 890.3860
The 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.
This Electric wheelchair 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 Electric wheelchair is composed of frame, motor, controller, lithium battery and seat cushion. The Electric wheelchair is powered by lithium 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.
The patient can activate the controller handle (joystick) to control the speed and direction of the Electric wheelchair movement. In addition, when the patient releases the joystick, it will return back to the central position and the Electric wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the Electric wheelchair will be re-energized.
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(105 days)
Trade/Device Name:* Electrically Powered Wheelchair (Model YC-01)
Regulation Number: 21 CFR 890.3860
Product code: ITI
Regulation Number: 890.3860
Review Panel: Physical Medicine
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The Electrically Powered 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.
The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger.
Electrically Powered Wheelchair is powered by Li-ion Battery pack (25.55V 10.4Ah*2) with 11.8 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 materials of frame is Carbon fiber.
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.
The max loading of the device is 136KG. Only for one person to sit.
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(88 days)
China
Re: K254206
Trade/Device Name: Power wheelchair (ZS-EW8026)
Regulation Number: 21 CFR 890.3860
ZS-EW8026
Regulatory Information
Classification: Class II
Product code: ITI
Regulation Number: 890.3860
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.
The product is intended only carry one person and used as a means of transportation for the disabled, the sick and the infirm.
The power wheelchair is classified as class A and the maximum occupant mass is 150kg.
The power wheelchair is a battery powered four wheeled vehicle.
It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back cushion, control system, armrest, two rear wheels, two casters(front wheels), foot pedal, anti-tip devices.
The power wheelchair can easily fold and unfold for transportation or storage.
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(99 days)
China
Re: K254012
Trade/Device Name: Electric Wheelchair (E201)
Regulation Number: 21 CFR 890.3860
Wheelchair(E201)
Regulatory Class: Class II
Product Code: ITI
Regulation Number: 21 CFR 890.3860
-------------|----------------------|
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860
| 21 CFR 890.3860 | Same |
| Device classification | Class II | Class II | Same |
| Product Name | Electric
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.
The product is a wheelchair which provides transport for the elderly and mobility-impaired individuals.
The maximum loading weight of the device is 100kg.
The wheelchair is a battery powered four wheeled vehicle.
It consists one Li-ion Battery with an off-board battery charger, frame, controllers, motors, seat, back support, control device (including: Power on/off, battery power indicator, horn button, speed indicator, speed up/down button, charging port), two rear wheels, two front wheels, foot support.
The wheelchair can easily fold for transportation or storage.
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(108 days)
K253849**
Trade/Device Name: Electric wheelchair (JJW-7002, JJW-7003)
Regulation Number: 21 CFR 890.3860
Classification name:* Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
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.
The subject device, Electric Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.
The Electric Wheelchair is a battery powered four wheeled vehicle. It consists of Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.
The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electric Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.
The braking time is about 1s, and the braking distance is ≤1.0m.
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(259 days)
city, Shizuoka 4388501
Japan
Re: K252101
Trade/Device Name: JWG-1
Regulation Number: 21 CFR 890.3860
Common Name | Powered wheelchair |
| Classification Name | Wheelchair, Powered |
| Regulation Number | 890.3860
The device JWG-1 is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.
The JWG-1 is an add-on drive for wheelchairs. The JWG-1 turns a manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.
The device consists of the left/ right drive units, controller, battery and the battery charger. The drive units replace the original wheels of the manual wheelchair.
Yamaha Li-ion battery JWB3 can be used for the device. They are recharged with the charger JWC4. Battery can be charged in detached 'desktop' condition and on the wheelchair condition. JWB3 does not supply the driving current during the charging to prevent the wheelchair to move.
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(90 days)
China
Re: K253870
Trade/Device Name: Electric Wheelchair (MP148)
Regulation Number: 21 CFR 890.3860
:MP148
Regulatory Information
Classification: Class II
Product code: ITI
Regulation Number: 890.3860
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.
The product is intended only carry one person and used as a means of transportation for the disabled, the sick and the infirm.
The electric wheelchair is classified as class A and the maximum occupant mass is 120kg.
The electric wheelchair is a battery powered four wheeled vehicle.
It consists one Lithium battery with an off-board battery charger, frame, controller system, motors, seat, back cushion, armrest, two rear wheels, two casters(front wheels), foot plate, anti-tip devices.
The electric wheelchair can easily fold and unfold for transportation or storage.
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(89 days)
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.
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(92 days)
China
Re: K253707
Trade/Device Name: Electric wheelchair (W1,W3)
Regulation Number: 21 CFR 890.3860
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.
Not Found
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(91 days)
Re: K253599**
Trade/Device Name: Electric Wheelchair (W-A807, W-A807L)
Regulation Number: 21 CFR 890.3860
Common Name | Powered wheelchair |
| Classification Name | Wheelchair, Powered |
| Regulation Number | 890.3860
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.
The Electric Wheelchair is a battery powered four wheeled vehicle.
The model W-A807 consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery indicator light, ON/OFF, speed indicator light, decrease speed, horn, joystick, charging port), arm supports, two rear wheels(drive wheel), two casters, foot support, anti-tip devices, handle.
The model W-A807L consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery indicator light, ON/OFF, speed indicator light, decrease speed, increase speed, horn, lean back, backrest recline, joystick, charging port), arm supports, two rear wheels(drive wheel), two casters, foot support, anti-tip devices, handle, linear actuator.
The wheelchair can easily fold and unfold for transportation or storage.
The wheelchair uses lithium battery as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is Aluminum. 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 solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the controller to achieve the rear wheels movement.
The DC Brushed Motor and brake system are fixed on the rear wheels.
The max loading of the device is 136 kg. Only for one person sit.
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