AccessGUDID - DEVICE: VRReliever (07290016986136)

GUDID

Device Identifier (DI) Information

Brand Name: VRReliever
Version or Model: PD-810 (Mindset)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VRReliever PD-810
Company Name: XR HEALTH IL LTD

Primary DI Number: 07290016986136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531893653 *Terms of Use

Device Description: The PD-810 ("Mindset") 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 PD-810 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The PD-810 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64245	Hypnotherapy virtual reality software	A virtual reality software program intended to be used with an appropriate off-the-shelf device in conjunction with a virtual reality headset (not included) to help reduce stress/anxiety by providing a patient with immersive imagery/sounds for relaxation hypnosis. It may be intended to sedate a patient or assist pain therapies. It is not intended to treat affective/mood disorders. It is intended to be used by patients in clinical settings, or at home under clinician consultation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISD	Exerciser, Measuring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0fd29e16-ec83-40b5-b43d-23e117e3c404
Public Version Date: July 06, 2022
Public Version Number: 4
DI Record Publish Date: June 15, 2021