A000-525; A002-461

Nom de l'organisation

medica Medizintechnik GmbH

SRN

DE-MF-000005058

Statut du fabricant

Actif

Marché principal en Allemagne ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04041925006179

Basic UDI-DI

4041925tigoFN

Numéro de référence/catalogue

A000-525; A002-461

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

The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The transition from passive to active therapy is seamless. The system is used in a seated position, e.g. in a wheelchair or suitable therapy chair. The movement is managed by two drive units which differentiate in upper and lower extremities. The drive unit for lower extremities is limited in extent by the selected crank radius. The drive unit for upper extremities is limited to one crank radius. Both drive units are never moved simultaneously. The therapy drive units for leg and arm do drive a supportive accessory for legs (footrests) and arms (therapy grips, arm support or arm rest) in a circular motion. The different accessories are interchangeable by the operator. With the user interface the operator is able to select a training type (upper extremity or lower extremity training) which activates the corresponding therapy drive unit. The medical device guarantees a non-slip and tilt resistant stand during the training preparation of the device as well as during the training. The device can be easily transported to different places of use or storage by means of castors and transport belt. The interfaces of the upper drive unit are designed in such a way that other accessory options are easy to attach. The requirements for the use of these accessories are derived from the degree of disability of the user.   The training of the upper extremities should be possible as an option and does not have to be present as a matter of principle.

URL des informations complémentaires

https://thera-trainer.com/en/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Y0599LEARNING AND TRAINING DEVICES - OTHER

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