VRReliever

Basic Information

• Brand Name: VRReliever
• Primary DI: 07290016986136
• Version / Model: PD-810 (Mindset)
• Catalog Number: VRReliever PD-810
• Company Name: XR HEALTH IL LTD
• Labeler DUNS: 531893653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-15
• Public Version: 4
• Public Version Date: 2022-07-06
• Public Version Status: Update
• Public Device Record Key: 0fd29e16-ec83-40b5-b43d-23e117e3c404

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISD	Exerciser, Measuring	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016986136	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]