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510(k) Data Aggregation
K Number
K242471Device Name
Power Wheelchair (W5538)
Manufacturer
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Date Cleared
2024-11-18
(90 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Innuovo Rehabilitation Devices 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
This Power wheelchair, W5538, is a motor driven, indoor 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 and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.
The device is powered by a Li-ion Battery pack (24V 12Ah, 288Wh) with 15 Km (9.3 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 user 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 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
K242387Device Name
Mobility Scooter (N3473)
Manufacturer
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Date Cleared
2024-10-11
(60 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The mobility scooter 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 mobility scooter 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 Mobility Scooter, Model N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. The movement of the scooter 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 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
K240012Device Name
Mobility Scooter (W3431)
Manufacturer
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Date Cleared
2024-05-02
(121 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
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 Mobility Scooter, Model: W3431, has a base with Steal frame, two front wheels, a seat, a tiller console, 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 control dial 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
K230964Device Name
Power Wheelchair (N5909)
Manufacturer
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Date Cleared
2023-12-13
(252 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power Wheelchair (N5909) 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
This Power wheelchair, N5909, is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.
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K Number
K231508Device Name
Power Wheelchair, W5521
Manufacturer
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Date Cleared
2023-11-09
(168 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power Wheelchair, W5521, 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
This Power wheelchair, W5521, is a motor driven, indoor 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 and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.
The device is powered by a Li-ion Battery pack (24V 10Ah, 240Wh) with 10 Km (6.2 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 user 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
K220740Device Name
Power Wheelchair, W5907 (Q50 R Carbon)
Manufacturer
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Date Cleared
2022-05-12
(59 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Innuovo Rehabilitation Devices 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
This Power 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 device consists of front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, pedal, battery box and charger. The device is powered by 2 Li-ion Battery pack (24V 10Ah, 240Wh) 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, 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
K220747Device Name
Power Wheelchair (N5515B)
Manufacturer
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Date Cleared
2022-05-12
(59 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power Wheelchair (N5515B) 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 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, pedal, battery box and charger.
The device is powered by Li-ion Battery pack (24V 12Ah) with 15 Km (9.32 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, 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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