600235

Nom de l'organisation

Focal Meditech BV

SRN

NL-MF-000000536

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en Pays-Bas ; disponible dans 5 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08719327649336

Basic UDI-DI

87193276493FOCBA1LM

Numéro de référence/catalogue

600235

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

URL des informations complémentaires

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

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

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