EZER 002

Nom de l'organisation

J58 Holding B.V.

SRN

NL-MF-000046315

Statut du fabricant

Actif

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

• CW999

  Warning: Ensure brakes are applied when stability is critical (standing, transfers, parking); inadequate braking or tyre pressure may reduce braking efficiency.
• CW999

  Warning: Keep clothing and loose items clear of wheels and moving parts; do not stand on the footplate when entering or exiting.
• CW999

  Warning: Children must not stand or play on the wheelchair.
• CW999

  Warning: Do not lift the wheelchair by removable parts; never disassemble or modify the frame structure — unauthorized repairs or modifications void the warranty and may cause injury.
• CW999

  Warning: During transport and storage, protect the release mechanism from pressure or accidental activation; ensure mechanism cannot be accidentally activated in a vehicle.
• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  Warning: Consult a doctor or physical therapist before using the standing function; not suitable without clinical assessment for users with strong spasms, cramps, involuntary movements, strong contractures, osteoporosis, amputation, or any condition that affects natural centre of gravity.
• CW999

  Warning: Always secure knee support and chest strap before activating the standing mechanism; never attempt to stand without these restraints.
• CW999

  Contra‑indication: Do not use the EZER with an unconscious person or by more than one user at a time.
• CW011

  The standing function must only be used on firm, level ground; activating the standing mechanism on inclines, uneven or unstable surfaces increases tipping risk.
• CW999

  Warning: Do not exceed maximum user weight of 120 kg; overloading can cause damage, malfunction, and safety hazards.
• CW999

  Warning: Do not use the wheelchair as a vehicle seat; users must be transferred to a vehicle seat for transport — the EZER is not approved for use as a vehicle restraint.

Marché principal en Pays-Bas ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

07649994843021

Basic UDI-DI

7649994843002JD

Numéro de référence/catalogue

EZER 002

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 EZER 002 Mechanical Standing Wheelchair is a product which changes people’s position from seating to standing and standing to seating.

URL des informations complémentaires

https://www.j58.eu/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• Y122106REAR SELF-PROPELLED WHEELCHAIRS

Ce dispositif n'est actuellement lié à aucun autre dispositif.