605988

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

08719327649459

Basic UDI-DI

87193276494FOCPA1PC

Numéro de référence/catalogue

605988

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 basic version of Papillon consists of three pads and a base. The three individually adaptable support pads are designed to suit heads with a diversity of shapes. The two elongated, waveshaped pads (the so called sub-occipital support pads) offer support under the ear and along the base of the head. This shape gives a good deal of comfort and, because they are somewhat funnel-shaped, the pads cushion the head. On the other hand, however, the head can be easily tilted if you want to adopt a more forward posture. Whilst support is more or less automatic, it’s not always necessary. The ends of the sub-occipital support pads, which come in Small, Medium or Large versions, curve noticeably outwards. Their shape is to ensure that the head of the user doesn’t get stuck behind the head support. The third pad is the so-called occipital support pad, which occupies a higher position to support the back of the head. This pad provides extra support behind the head and acts as a safety measure to any backward movement of the head. The occipital pad should not allow the head of the user to be pressed forwards from the sub-occipital support pads. Together, the three pads, if mounted correctly should leave the ears and the shoulders free.

URL des informations complémentaires

https://www.focalmeditech.nl/papillon/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• Y181899SUPPORT SYSTEMS - OTHER