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510(k) Data Aggregation
K Number
K072475Device Name
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
Manufacturer
Date Cleared
2007-12-21
(108 days)
Regulation Number
890.3900Why did this record match?
Applicant Name (Manufacturer) :
ETAC SVERIGE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac are indoor/outdoor battery operated multifunctional wheelchairs. The intended use of these powered wheelchairs is to provide mobility to persons that have the capability of operating a powered wheelchair.
Device Description
The Balder Finesse and Balder Junior powered wheelchairs are front-wheel driven power wheelchairs that have been designed and developed to be used in both indoor and outdoor environments. and to transport one (1) person at a time. The wheelchairs are outfitted with a seat lift, so that its user can reach objects on high shelves as well as slide their legs under the table when seated. The Balder Finesse and Balder Junior powered wheelchairs can also be purchased with a stand-up function option that allows the user to be placed in a stand-up position, thus allowing them to operate the wheelchair while standing. The Balder Finesse and Balder Junior powered wheelchairs operate using an electric, front-wheel drive motor that is driven by two (2) 12 Volt, 52 Amp dry cell batteries, and contains a D.C. permanent magnet type motor that uses graphite-copper brushes with integrated brakes (12/24V). The wheelchair frame is of welded steel construction and includes the rear castor wheels, front driving wheels with drive motor (i.e., motor, gear, brakes) and batteries. The motor controller, with joystick, can be mounted on either the left or right armrest depending on the user's needs. The motor controller, with joystick and software that is found in each wheelchair is manufactured by Dynamic Controls, a division of Invacare Corporation, and was previously cleared by the FDA on May 12, 1997 (see K970094).
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