VRReliever - The MD-710 ("Relax8") is intended to assist in - XR HEALTH IL LTD

Duns Number:531893653

Device Description: The MD-710 ("Relax8") is intended to assist in relaxation and self-management of pain and The MD-710 ("Relax8") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The MD-710 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The MD-710 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. MD-710 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.

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More Product Details

Catalog Number

-

Brand Name

VRReliever

Version/Model Number

MD-710 (Relax8)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ISD

Product Code Name

Exerciser, Measuring

Device Record Status

Public Device Record Key

05006511-1c23-4100-9dd5-12fb61fa05ec

Public Version Date

September 16, 2022

Public Version Number

7

DI Record Publish Date

January 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XR HEALTH IL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14