Eu Mdr Eu Md Class 1 On The Market πŸ‡³πŸ‡± Netherlands

Balancer

Focal Meditech BV Β· πŸ‡³πŸ‡± Netherlands
Devices (same UDI-DI)
2
Certificates
0
Countries
5
Notified Bodies
0

Basic Information

Primary DI
08719327649329
Basic UDI-DI Code
87193276493FOCBA1LM
Reference
600236
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Focal Meditech BV

Additional Description

The dynamic arm support system Balancer is a system that consists of several beams which are interconnected via pivoting points. The beams are connected to a manually adjustable gravity compensation mechanism. At the distal end of the system an arm fitting and elbow fitting attached. Balancer is mounted on the β€˜solid’ world (wheel or working chair or stand). The lower arm of the user is placed in the arm fitting, and Balancer can support the weight of the under and partly the upper arm. The rotatable beam will support movements of the human underarm and hand. Balancer has a robust design combined with low friction and low play. This is realised by using high quality bearing systems combined with high accuracy mechanical parts which results in a smoothly running system. Therefore, little energy is required to introduce the intended movements. The smooth-running Balancer combined with the accurate fit of the arm fitting results in little muscle forces required of the user. The setup of the rotation axis and use of rope to transmit the balancing force results in a large range of motion. Gravity compensation characteristics of the device can depend on individual requirements easily be adjusted.

CND Nomenclature Codes

Code Description
Y241899 ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER

Available In Countries

πŸ‡§πŸ‡ͺ Belgium πŸ‡©πŸ‡ͺ Germany πŸ‡©πŸ‡° Denmark πŸ‡«πŸ‡· France πŸ‡³πŸ‡± Netherlands

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