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510(k) Data Aggregation
K Number
K140706Device Name
LEVO MAX
Manufacturer
LEVO AG
Date Cleared
2015-01-21
(306 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
LEVO AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LEVO MAX power wheelchair is intended to provide indoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.
The LEVO MAX power wheelchair is intended to provide indoor and outdoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.
Device Description
The LEVO MAX powered wheelchair with optional seating and function is center wheel motor driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "R-net" or "VR2". The joystick user interface is integrated in the controller. The wheelchair is powered by two 12V/55Ah, 12V/73Ah or two 12V/75Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah); with fully charged batteries.
Components:The LEVO MAX power wheelchair consists of three basic sub-sections. These are: the base with drive units, the PG Drives Technology's R-NET or VR-2 Control System, and the body supporting system.
The base of the LEVO MAX includes: the frame, two direct-drive units with integrated parking brakes, two 12V/55Ah, two 12V/73Ah, or two 12V/75Ah batteries, two straight front and two center driving wheels as well as two twin rear caster wheels.
PG Drives Technology's VR2-Control System includes the power module, the integrated lighting module and the controller with integrated joystick. PG Drives Technology's R-NET Control System includes the power module, the intelligent seating/lighting module and the controller with integrated joystick.
The body supporting system includes the seat support, armrests and leg rests.
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K Number
K083017Device Name
LEVO C3
Manufacturer
LEVO AG
Date Cleared
2008-10-24
(15 days)
Product Code
IPL
Regulation Number
890.3900Why did this record match?
Applicant Name (Manufacturer) :
LEVO AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LEVO C3 power wheelchair with optional seating and standing position function may be of interest for any individuals who needs a power wheelchair and cannot stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.. The LEVO C3 power wheelchair is a product which changes people's position in/from seating or/to standing but also any position in between. The product provides high indoor and outdoor mobility.
Device Description
The LEVO C with optional seating and standing position function is center wheel driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "VR2". The joystick is integrated in the controller. The wheelchair is powered by two 12V/55Ah or two 12V/72Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah). The electrical positioning change is integrated in an electrical center wheel drive power wheelchair that performs high indoor and outdoor mobility in any optional possible position. For security, the speed is reduced to half speed as soon as the patient is not in the sitting position.
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K Number
K051387Device Name
LEVO COMFORT II
Manufacturer
LEVO AG
Date Cleared
2005-06-10
(14 days)
Product Code
IPL
Regulation Number
890.3900Why did this record match?
Applicant Name (Manufacturer) :
LEVO AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LEVO comfort II stand-up power wheelchair may be of interest for any individuals who needs a power wheelchair and can not stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Intended use: The LEVO comfort II stand-up power wheelchair is a product which changes people's position from sitting to Standing to sitting but also any position in between. The product provides indoor and outdoor mobility.
Device Description
The LEVO comfort II power wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the PG Drives Technology's power wheelchair controller "VSI" The Joystick is integrated in the Controller. The wheelchair is powered by: two 12V/26Ah, two 12V/40Ah or four 12V/26Ah batteries with a theoretical driving range of 14km (26Ah), 20km (40Ah) or 28km (56Ah) on the fully charged batteries.
The wheelchair consists of the following basic sub-sections:
- Base with two direct-drive units with integrated parking brakes, two 12V/26Ah, two 12V/40Ah or four 12V/26Ah, two 14"x2%" rear wheels and two 8"x2" front wheels.
- PG Drives Technology's power wheelchair controller . "VSI"
- Seating System including stand-up mechanisms and actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, rear driving wheels with drive unit (motor/gear/brakes) and batteries. The motor Controller is mounted to the left or right armrest, depending on the user's needs.
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K Number
K030893Device Name
LEVO COMBI
Manufacturer
LEVO AG
Date Cleared
2003-04-02
(12 days)
Product Code
IPL
Regulation Number
890.3900Why did this record match?
Applicant Name (Manufacturer) :
LEVO AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LEVO combi stand-up electrical power wheelchair is a product which changes peoples position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Device Description
The LEVO combi powered wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact power wheelchair controller Pilot+. The joystick is integrated in the controller. The wheelchair is powered by two 12V55Ah batteries with a theoretical driving range of 35km on the fully charged batteries. The wheelchair consists of the following basic sub-sections:
- Base with two direct-drive units with integrated parking brakes, two 12V55Ah batteries, two 14"x2¾" centre wheels, two 8"x2" front wheels, and one 5½"x1½" rear wheel with suspension.
- Penny & Giles power electronics Pilot+.
- Seating system including mechanisms for all possible positions, stand-up actuator and optional lift and/or backrest actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, centre driving wheels with drive unit (motor/gear/brakes), batteries and pivoting rear castor. The motor controller is mounted to the left or right armrest, depending on the user's needs.
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