FDA.reportPublic FDA data

RelieVRx

Primary DI
00850038247119
Brand
RelieVRx
Company
Appliedvr, Inc.
Model
RVX-3011
Device description
RelieVRx is an at-home immersive virtual reality (VR) pain treatment indicated as adjunctive treatment for chronic lower back pain (CLBP).
Published
2025-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRAVirtual Reality Behavioral Therapy Device For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRAVirtual Reality Behavioral Therapy Device For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243417000RelieVRxAppliedvr2024-12-04QRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850038247119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038247119008500382471198500382471190850038247119

GMDN Terms#

Term, Definition table
TermDefinition
Pain relief virtual reality systemAn 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.

Contacts#

Phone, Email table
PhoneEmail
(844) 728-4487Support@AVRPathway.com

Regulatory Flags#

DUNS number
080429668
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038247140RelieVRxRVX-30022025-11-20
00850038247157RelieVRxRVX-30122025-11-20
00850038247164RelieVRxRVX-30222025-11-20
00850038247171RelieVRxRVX-30322025-11-20
00850038247102RelieVRxRVX-30012025-01-16
00850038247126RelieVRxRVX-30212025-01-16
00850038247133RelieVRxRVX-30312025-01-16
00850038247072RelieVRxRVX-2052RVX-20522024-02-07
00850038247089RelieVRxRVX-2062RVX-20622024-02-07
00850038247096RelieVRxRVX-2072RVX-20722024-02-07
00850038247065RelieVRxRVX-2042RVX-20422023-07-12
00850038247058RelieVRxRVX-2032RVX-20322023-05-31
00850038247034RelieVRxRVX-2012RVX-20122023-04-28
00850038247041RelieVRxRVX-2022RVX-20222023-04-28
00850038247027RelieVRxRVX-20022023-02-08
00850038247010RelieVRxRVX-20012022-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850038247140RelieVRxAppliedvr, Inc.QRA2025-11-20
00850038247157RelieVRxAppliedvr, Inc.QRA2025-11-20
00850038247164RelieVRxAppliedvr, Inc.QRA2025-11-20
00850038247171RelieVRxAppliedvr, Inc.QRA2025-11-20
00850038247102RelieVRxAppliedvr, Inc.QRA2025-01-16
00850038247126RelieVRxAppliedvr, Inc.QRA2025-01-16
00850038247133RelieVRxAppliedvr, Inc.QRA2025-01-16
00850038247072RelieVRxAppliedvr, Inc.QRA2024-02-07
00850038247089RelieVRxAppliedvr, Inc.QRA2024-02-07
00850038247096RelieVRxAppliedvr, Inc.QRA2024-02-07
00850038247065RelieVRxAppliedvr, Inc.QRA2023-07-12
00850038247058RelieVRxAppliedvr, Inc.QRA2023-05-31
00850038247034RelieVRxAppliedvr, Inc.QRA2023-04-28
00850038247041RelieVRxAppliedvr, Inc.QRA2023-04-28
00850038247027RelieVRxAppliedvr, Inc.QRA2023-02-08
00850038247010RelieVRxAppliedvr, Inc.QRA2022-08-18