Magnes Nushu

Nom de l'organisation

Effectum Medical AG

SRN

CH-MF-000012474

Statut du fabricant

Actif

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

• CW999

  Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Magnes NUSHU, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result
• CW999

  Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally
• CW999

  Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• CW999

  It is possible that high levels of interference due to close proximity or due to the power of a source, disrupts the operation of this device. Medical electrical devices require special precautions regarding electromagnetic compatibility and all devices must be installed and put into service in accordance with the information specified in this user manual.

Marché principal en Suède ; disponible dans 3 pays au total.

Dénomination commerciale

Magnes Nushu

Code d'UDI-DI

07640255020564

Basic UDI-DI

764025502Magnes-NuShuXY

Numéro de référence/catalogue

010.001.010

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Magnes NUSHU is a medical device that enables patients to collect data on their gait and share this data with healthcare professionals (HCPs). Magnes NUSHU can help patients with gait deficits by providing them with notifications via vibrations on how they walk to assist normal walking. Magnes NUSHU allows to perform standard gait assessments and exercises. Magnes NUSHU Web Application is intended to be used by HCPs to visualize and track the walking parameters collected by patients using Magnes NUSHU. The data collected by Magnes NUSHU can be used to infer changes in the condition of patients.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Y99DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER

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