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510(k) Data Aggregation
K Number
K221215Device Name
e-motion M25
Manufacturer
Alber GmbH
Date Cleared
2022-05-24
(27 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Alber GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The e-motion M25 DuoDrive is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
Device Description
The e-motion-M25 DuoDrive is a medical device for active wheelchair users who are reliant on a wheelchair as a result of their disability. The subject device e-motion is an additional drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven and thus significantly increasing the wheelchair user's mobility and flexibility. To extend functionality an optional remote control (ECS) a smartphone app and a detachable control unit is available. The user interacts with the e-motion M25 DuoDrive via two push-rims that trigger the assistive power drive. The main parts of the drive unit are as follows: Pushrim-wheels including a brushless DC-motor. Control electronic for the motor and wireless interface for communication with ECS remote control and smartphone app. Integrated lithium ion battery pack with battery management system. Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery charger. Quick-release axle for attaching and detaching the drive unit to wheelchair-frame. The main function of the APP are as follows: Status information (battery, speed). Live display of error messages. Recording of tours. Selection of preset driving profiles. ECS functionality (extra charge, details see below). Wheelchair navigation (extra charge). Enhance maximum speed (extra charge). Cruise mode (extra charge). Activation flight mode. System information. Error logfile (password protected). Setting auto shut-off time (password protected). Individual adjustment of driving parameters (password protected). The main function of the ECS remote control are as follows: Switch between 2 assist level for indooir and outdoor. Selection of learner mode (formerly also called Training mode). Activation of rollback delay (hill holder). Switch the wheels on and off (standby mode). The main parts of the control unit are as follows: Wireless interface for communicating with the drive wheels. Rotary wheel to start and change the cruise speed. Rotary wheel to stop cruise mode (short push on the side). Rotary wheel to switch the drive wheels on and off/standy mode (long push on the side). Integrated Li-ion battery cell including battery management system. USB-C socket for charging via drive unit or other external USB-C charger. Display for operating status and remaining capacity of drive wheels and control unit. To charge the battery of the drive unit a battery charger is available. Main attributes: Multi-range charger 100-240 VAC, 50-60 Hz. Automatic charging and switch-off mechanism. Indicating status and mains.
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K Number
K192618Device Name
e-Motion M25
Manufacturer
Alber GmbH
Date Cleared
2020-11-02
(406 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Alber GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The e-motion M25 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
Device Description
The e-motion-M25 is a medical device for active wheelchair users who are reliant on a wheelchair as a result of their disability. The subject device e-motion is an additional drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven and thus significantly increasing the wheelchair user's mobility and flexibility.
To extend functionality an optional remote control (ECS) and a Smartphone App is available.
The user interacts with the e-motion M25 via push-rim that triggers the assistive power drive.
The main parts of the drive unit are as follows:
- Pushrim-wheels including a brushless DC-motor .
- Control Electronic for the motor and wireless interface for communication with ECS and . smartphone App
- . Integrated lithium ion battery pack with battery management system
- Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery charger
- Quick-release axle for attaching and detaching the drive unit to wheelchair-frame .
The main function of the APP are as follows:
- Status information (Battery, Speed)
- Live display of error messages ●
- Recording of tours
- Selection of preset driving profiles ●
- ECS-Funtionality (extra charge , details see below) ●
- Wheelchair navigation (extra charge)
- Enhance maximum speed (extra charge) ●
- . Cruise Mode (extra charge)
- Activation flight mode ●
- System information ●
- Error logfile (password protected)
- Setting auto shut-off time (password protected) ●
- Inidivial adjustment of driving parameters (password protected) ●
The main function of the ECS are as follows:
- Drive-Mode
- Settings ●
- Diagnostics ●
To charge the battery of the drive unit a battery charger is available. Main attributes:
- . Multi-range charger 100-240 VAC, 50-60 Hz
- . Automatic charging and switch-off mechanism
- Indicating status and mains ●
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K Number
K192016Device Name
SMOOV O10
Manufacturer
Alber GmbH
Date Cleared
2020-05-19
(295 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Alber GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SMOOV O10 add-on drive for wheelchairs is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. It is 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 SMOOV O10 drive unit is attached and detached to rigid wheelchairs via a bracket or alternatively to a foldable wheelchair with an optional adapter. The SMOOV 010 converts the user´s manual wheelchair, when needed, in a partly motorized wheelchair to extend the mobility and flexibility of the wheelchair user. To extend functionality an optional Smartphone App is available. The user interacts with the SMOOV 010 via control unit mounted to the wheelchair for wireless interfacing with the drive unit. The control unit is used to switch on and off the power assistance and adjust the speed of the drive unit via the turnwheel.
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K Number
K161241Device Name
e-fix E35/E36
Manufacturer
Alber GmbH
Date Cleared
2016-10-05
(156 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Alber GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 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.
Device Description
The subject device e-fix E35/E36 is an add-on drive, which converts a manual wheelchair into an electrical wheelchair.
The drive system e-fix E35/E36 includes two power wheels, a battery mount, a battery pack, a control unit, a power supply and optional devices. The wheelchair is not part of the drive system and is provided by the customer. For initial use mounting brackets are required. If the mounting brackets are fitted to the wheelchair, the power wheels, the control unit and the battery pack can be adapted. The main principle of the power wheel is that the motor unit is fixed against turning and the wheel hub is rotating. The fixing of the motor unit to the mounting brackets is realized with the wheel receiver. The wheel receiver supports the torque which the motor applies and is the interface to the wheel chair.
There are different variants of the e-fix E35 is the conventional version of the e-fix. The e-fix E36 provides a more robust drive with a higher torque. The battery pack has more capacity than the normal one. The e-fix E36 is mainly intended for heavy-weighted persons. The e-fix E35 and E36 are available with 22" or 24" wheels. The control unit is the steering device of the system. It allows a safe and comfortable ride with the wheelchair.The battery pack is easily removable and rechargeable.
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K Number
K151717Device Name
twion
Manufacturer
Alber GmbH
Date Cleared
2016-02-23
(243 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Alber GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The twion is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
Device Description
The twion is a power assist drive system. Its basic functionality can be compared to a power steering of a car. By pushing the push rim attached to the wheel, a motor assists in turning the wheel - like a power steering does when turning the steering wheel.
The intent of the twion device is to expand the field of activities for those wheelchair drivers who are limited in their physical condition.
The twion is designed to fit most standard manual wheelchairs available on the market. It is lightweight and with motors and batteries designed inside the wheelhubs it does not compromise the usability and safety of such wheelchairs. The twion can be driven without power assist very close to a manual wheelchair.
Each hub motor is equipped with a DC motor and an integrated battery. A push rim sensor detects the force applied by the wheelchair driver. An integrated microcontroller converts this signal into a proportional motor output which generates an additional torque to the wheel. This torque by itself is very low but enables the driver to drive the wheelchair manually.
The benefit for the wheelchair driver is such that he can keep driving in his manual wheelchair. Without a device like the twion, the patient would have to use a fully electrical wheelchair (with joystick).
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K Number
K042535Device Name
ADVENTURE A10
Manufacturer
ULRICH ALBER GMBH
Date Cleared
2004-10-05
(15 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
ULRICH ALBER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A wheelchair can be provided as a result of medical indication where walking is no longer possible or the ability to walk is severely restricted through:
- paralysis ●
- . loss of a limb or limbs
- . defects/deformation of a limb or limbs
- . contractures of the joints
- . other illnesses
The intended use of the wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair
Device Description
The Adventure A10 wheelchair is a lightweight wheelchair with full spring suspension and extremely good outdoor driving characteristics which can also be used indoors without any problems, due to its maneuverability.
All components are made of non-corrosive materials or have an anti-corrosive surface.
The housing for electronic components and all plug connections fulfill the IPX4 degree of protection. The permitted operating temperature lies between -25°C and +50°C.
In addition to the comfort offered on normal asphalted streets, roads and paths, the A10 also offers a high degree of driving comfort on cobbled streets and, in particular, on field and forest paths and on level meadows. This is realized through its chassis with full spring suspension, longitudinal steering wheels and individual wheel suspension elements. Spring travel is 52 mm.
Obstacles up to a height of 120 mm can be negotiated with the aid of a curb climber included in the accessories.
The tires are designed to achieve good rolling characteristics and noise-free operation on smooth surfaces, both indoors and outdoors. The integrated cleat tread provides the required traction in off-road use.
The tilt supports secure the vehicle against tilting backwards when negotiating obstacles and slopes. The Adventure can be raised on the drive wheels with the integrated jack-up mechanism to facilitate their removable and refitting.
The Adventure can be rapidly and simply dismantled into 8 individual components without tools or aids, thanks to the modular construction. Contact is established automatically during this with the drives and battery packs.
The modular construction of the Adventure means it can also be transported easily in smaller vehicles. Defective components can be replaced quickly in the event of a breakdown, meaning that long periods of disuse are avoided and there is no longer any need to send the entire wheelchair in for repairs.
The logical lightweight construction means that the max, empty weight is 96.7 kg (without accessories). The weight of individual removable components is derived as follows:
The image shows an exploded view of a wheelchair and its components. The seat unit weighs 14.3 kg, the chassis weighs 26.2 kg, and each wheel weighs 11.2 kg. The steering wheel weighs 2.3 kg each, and each battery pack weighs 14.6 kg.
The max. permissible occupant weight is 140 kg. The permissible overall weight is 255 kq. Slopes and gradients up to 18% and sloping ground up to 12% can be safely traversed, thanks to the optimally positioned center of gravity of the Adventure.
The compact dimensions of the Adventure, with an overall length of 1100 - 1300 mm (depending on the setting of the seat angle and leg supports), a max. width of 680 mm and a turning radius of 950mm enable its easily handling, even indoors. An option exists for switching the control on the control panel to indoor mode, enabling better control of the vehicle in confined spaces.
The removable seat is available in standard and function seat versions. The standard seat is equipped with washable, non-removable seat padding and has limited adjustment functions.
The function seat version is available with standard or comfort padding, each of which is removable and washable.
In contrast to the standard seat, the function seat has continuous adjusting options for both the back and leg supports. The seat width, depth and back height can also be varied.
The armrests are removable or can be simply pivoted to the rear (to facilitate movement of the occupant).
The Adventure is equipped with a parking brake which can be actuated by the driver. The Adventure can be pushed by an accompanying person when the parking brake is released and the system deactivated.
The various driving parameters which can be adapted to suit the occupant's disability can be edited directly on the control panel without an additional external programming unit.
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K Number
K003449Device Name
E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
Manufacturer
ULRICH ALBER GMBH & CO.
Date Cleared
2001-03-16
(129 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
ULRICH ALBER GMBH & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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