BraceID-High Regular Walker - STD Liner-Small (36-39)

Dénomination commerciale

BraceID-High Regular Walker - STD Liner-Small (36-39)

Code d'IUD-ID

05404020401178

IUD-ID de base

5404020402anklefootAV

Numéro de référence/catalogue

12-0001-S

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

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• Small = 36-39 (EU)

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

• Y06120601PASSIVE ANKLE-FOOT ORTHOSES

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW011

  Contraindications • Not intended for unstable fractures or fractures of the proximal tibia or fibula. Precautions & Warnings • This device should be prescribed by a qualified health care professional who also determines frequency and duration of use. • It should not be prescribed for patients with impaired sensations. • Do not over-inflate air chamber nor over-tighten Velcro straps. These may compromise blood circulation and cause significant skin irritation, especially if used for people with diabetic neuropathy. Frequently perform circulation checks. In case of any skin discoloration or feelings of discomfort, deflate air chamber to a comfortable level. Consult your health care provider immediately if discomfort persists. • In high altitude conditions, the air chambers will expand beyond optimal level. Adjust the compression level by deflating the air chambers or loosening the Velcro straps. • Use caution when walking on a slippery or wet surface to avoid injury
• CW010

  The brace should only be applied in accordance with the instructions for use.
• CW262

  • The product is intended for single patient use.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.