Eu Mdr Eu Md Class 1 On The Market

DREAM + HypnoVR 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 is a virtual reality hypnosis solution intended to improve management of patients’ pain, stress and anxiety by providing an alternative or complementary solution to chemical treatments. HypnoVR 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
03770022767461
Basic UDI-DI Code
3770022767DREAMHVRUF
Reference
DREAM + HypnoVR System
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

The DREAM + HypnoVR system is the combination of the Paperplane 4.X software application, the Launcher 1.X software application, the HypnoVR software (HypnoVR software V3.X.Y + Compagnon software V7.X.Y), a virtual reality headset Pico 4 Ultra, an audio headset Ankbit E500 Pro, and a tablet Lenovo Tab M9.

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 is a virtual reality hypnosis solution intended to improve management of patients’ pain, stress and anxiety by providing an alternative or complementary solution to chemical treatments. HypnoVR 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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