600235

Organization name

Focal Meditech BV

SRN

NL-MF-000000536

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 5 countries total.

Trade name

not provided

UDI-DI code

08719327649336

Basic UDI-DI

87193276493FOCBA1LM

Reference / catalog number

600235

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product 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 ‘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.

Additional information URL

https://www.focalmeditech.nl/balancer/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y241899ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER