AccessGUDID - DEVICE: RelieVRx (00850038247102)

GUDID

Device Identifier (DI) Information

Brand Name: RelieVRx
Version or Model: RVX-3001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Appliedvr, Inc.

Primary DI Number: 00850038247102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080429668 *Terms of Use

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

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QRA	Virtual Reality Behavioral Therapy Device For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243417	000

Device Exempt from Premarket Submission: No 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: 978548a3-ca5a-4b20-9de2-d37a1b76e0f5
Public Version Date: January 24, 2025
Public Version Number: 1
DI Record Publish Date: January 16, 2025