FDA.reportPublic FDA data

VRBehavior

Primary DI
07290016986167
Brand
VRBehavior
Company
XR HEALTH IL LTD
Model
VRET-910 (Expose)
Device description
The VRET-910 "Expose" is a prescription-only medical software used as a tool by Licensed Healthcare Provider (LHP) in order to immerse their patients into virtual reality (VR) and 360 degree simulated environments, as part of remote or in-person therapy sessions devised to improve certain mental health conditions. The software can be used in clinical settings or at home, with or without the assistance of a licensed healthcare provider.
Published
2024-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ISDExerciser, Measuring

Product Code Classifications

CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290016986167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290016986167072900169861677290016986167

GMDN Terms

TermDefinition
Hypnotherapy virtual reality softwareA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (857)-990-6111support@xr.health

Regulatory Flags

DUNS number
531893653
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07290016986174XRBehaviorVRMM-920 (Mind&Motion)2026-01-26
07290016986181XRBehaviorVRFR-930 (First Resort)2026-01-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199874272399SeniorLife.AISENIORLIFE TECHNOLOGIES INC.ISD2026-03-11
00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
00860014763700Aspire MotionSurge Motion Inc.ISD2025-11-14
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
G741WHREHABV10Waya RehabWELLOVATE, LLCISD2025-02-03
G186EXERSCAN20Exer ScanExer Labs, Inc.ISD2024-09-03
00850067173007Opal V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
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00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24
00850064651058DS6Foresite Healthcare, LLCISD2024-05-24
00850064651065DS6Foresite Healthcare, LLCISD2024-05-24
00815948029460REAL y-SeriesPENUMBRA, INC.ISD2024-04-16
00815948029477REAL y-SeriesPENUMBRA, INC.ISD2024-04-16
00815948029484REAL y-SeriesPENUMBRA, INC.ISD2024-04-16
00860010519905Humero TechTitin Km Biomedical Corp.ISD2024-01-31
05065013876009Digital TherapistSWORD HEALTH, S.A.ISD2023-09-07
00718175001462BiodexBIODEX MEDICAL SYSTEMS, INC.ISD2023-08-02
00718175001486BiodexBIODEX MEDICAL SYSTEMS, INC.ISD2023-08-02
04059358002224optibike basicergoline GmbHISD2023-05-12
04059358001821ergoselect 1ergoline GmbHISD2023-05-10
04059358002231ergoselect 12ergoline GmbHISD2023-05-10
04059358002248ergoselect 10ergoline GmbHISD2023-05-10