Eu Mdr Eu Md Class 2a On The Market

HypnoVR Biofeedback System

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, a tablet and a sensor.

Devices (same UDI-DI)
4
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
03770022767508
Basic UDI-DI Code
3770022767HBiofeedbackSUE
Reference
HypnoVR Biofeedback System
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

The HypnoVR Biofeedback system is the combination of the HypnoVR Biofeedback product (HypnoVR Biofeedback V3.X.Y software and Compagnon Biofeedback V3.X.Y software), 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

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, a tablet and a sensor.

CND Nomenclature Codes

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

Related Devices

The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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