Eu Mdr Eu Md Class 2a On The Market

DREAM + HypnoVR Biofeedback System

DREAM is a virtual reality therapy software designed to help manage procedural pain and anxiety in pediatric patients during various medical procedures. It is a software that provides an immersive, non-pharmacological alternative or complementary solution to standard pharmacological treatments. By engaging patients in a calming and interactive VR environment, DREAM aims to distract and alleviate the perception of pain and/or anxiety associated with medical procedures. HypnoVR Biofeedback is a virtual reality hypnosis solution with or without biofeedback intended to improve management of patients’ pain, stress and anxiety by providing an alternative or complementary solution to chemical treatments. HypnoVR Biofeedback is used with a virtual reality headset, an audio headset, and a tablet.

Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
03770022767522
Basic UDI-DI Code
3770022767DREAMHVRBIO4A
Reference
DREAM + HypnoVR Biofeedback System
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

The DREAM + HypnoVR Biofeedback system is the combination of the Paperplane 4.X software, the Launcher V1.X, the HypnoVR Biofeedback product (HypnoVR Biofeedback software V3.X.Y + Compagnon Biofeedback software V3.X.Y), a virtual reality headset Pico 4 Ultra, an audio headset Ankbit E500 Pro, a tablet Lenovo Tab M9, a sensor Bittium Faros 180, an electrodes cable IEC 2-electrode 1-CH patient cable 125mm, and a positioning pad HRV001-CCC.

Medical Purpose

DREAM is a virtual reality therapy software designed to help manage procedural pain and anxiety in pediatric patients during various medical procedures. It is a software that provides an immersive, non-pharmacological alternative or complementary solution to standard pharmacological treatments. By engaging patients in a calming and interactive VR environment, DREAM aims to distract and alleviate the perception of pain and/or anxiety associated with medical procedures. HypnoVR Biofeedback is a virtual reality hypnosis solution with or without biofeedback intended to improve management of patients’ pain, stress and anxiety by providing an alternative or complementary solution to chemical treatments. HypnoVR Biofeedback is used with a virtual reality headset, an audio headset, and a tablet.

CND Nomenclature Codes

Code Description
V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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