NedMano/IBV

Nom de l'organisation

ASOCIACIÓN INSTITUTO DE BIOMECÁNICA DE VALENCIA (I.B.V.)

SRN

ES-MF-000004011

Statut du fabricant

Actif

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

• CW999

  Absolutely contraindicated: Risk of damage or inconsistency of your practice. The identified cases are the following: - Instability due to fracture/tendon section/surgical intervention in the hand < 3 months. - Wound, unhealed burn or metastasis in the area of contact with the dynamometer. - Amputations or serious deformities of the 1st, 2nd, or 3rd fingers. - Muscle balance of 2 out of 5 (does not defeat gravity) or less. - States of intoxication. - Any other case in which, according to clinical criteria, the execution of the test may pose a risk of harm to the patient. Relatively contraindicated: The current clinical status or other types of pathologies interfere with the correct performance of the tests. The identified cases are the following: - Inability to properly position the upper limb. - Joint stiffness of the wrist and/or hand. - Dystonias and/or choreo-athetotic or uncontrolled movements, spasticity, Parkinson's, etc. - Outbreaks of myasthenia or multiple sclerosis. - Recent sutures or immobilizations. Sutures in areas of tension. - Crisis of anguish or hyperventilation. - Intellectual disability, severe visual impairment, psychiatric disorders or medication that interferes with the understanding and performance of the test. - Any other case in which, according to clinical criteria, the patient is unable to perform the tests adequately.
• CW010

  The product label includes the "Read the instructions for use" symbol.

Marché principal en Espagne ; disponible dans 1 pays au total.

Dénomination commerciale

NedMano/IBV

Code d'UDI-DI

08437020286015

Basic UDI-DI

8437020286NedMano_PSBD

Numéro de référence/catalogue

NedMano_PS

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

To assist assessment specialists in studying functional impairments of the hand’s musculoskeletal system by quantifying the isometric force exerted during a series of standardised tests (grip strength, distal pinch and lateral pinch), using a grip dynamometer.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z129092VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE

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