HELP v1.x.x

Nom de l'organisation

NEXTEC medical GmbH

SRN

DE-MF-000005572

Statut du fabricant

Actif

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

04260705080141

Basic UDI-DI

426070508MD-helpDiGA2579

Numéro de référence/catalogue

HELP v1.x.x

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

HELP is a digital health application that supports self-management in patients with chronic pain. Based on a biopsychosocial approach to pain, the app integrates various concepts of modern pain research, including Pain Reprocessing Therapy (PRT) and Emotional Awareness and Expression Therapy (EAET). Patients are supported in actively changing the way they deal with pain and developing new coping strategies. The aim of the digital application is to reduce pain interference and intensity, strengthen self-efficacy and systematically break the cycle of pain and anxiety. This is achieved by providing patients with information on pain-related topics such as its development, maintenance, chronification and psychoeducation. The topics are presented clearly in the form of videos, audios, graphics and texts. HELP is designed for independent use and can be used to complement multimodal pain therapy or to provide support while waiting for treatment. The application is not intended for diagnosis or therapeutic decision-making and does not replace medical professionals.

URL des informations complémentaires

https://help-app.de/wp-content/uploads/2025/08/HELP-IFU-v01-00_clean.pdf

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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