RelieVRx

Basic Information

• Brand Name: RelieVRx
• Primary DI: 00850038247010
• Version / Model: RVX-2001
• Company Name: Appliedvr, Inc.
• Labeler DUNS: 080429668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-18
• Public Version: 1
• Public Version Date: 2022-08-26
• Public Version Status: New
• Public Device Record Key: 3c6ece40-5291-4720-b5f3-a69a094cdd74

Device Description

RelieVRx is an at-home immersive virtual reality (VR) pain treatment indicated as adjunctive treatment for chronic lower back pain (CLBP).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• 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
QRA	Virtual Reality Behavioral Therapy Device For Pain Relief	Neurology	890.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66350	Pain relief virtual reality system	An electrically-powered virtual reality (VR) device assembly intended to help relieve chronic pain (e.g., back pain, osteoarthritis) by providing a patient with immersive visual techniques and distractions to self-manage pain (e.g., breathing techniques, interactive games, mindfulness, cognitive behavioural therapy), sometimes with supplemental educational information. It consists of a headset with user interface and controls, and preinstalled VR software. It is intended to be used by a patient at home under clinician consultation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850038247010	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN210014	000