FDA.report

XRBehavior

Primary DI
07290016986181
Brand
XRBehavior
Company
XR HEALTH IL LTD
Model
VRFR-930 (First Resort)
Device description
The VRFR-930 First Resort is a prescription only software application that provides virtual-reality–based measurements and exercises designed to support the self-management of stress, anxiety, and physical discomfort. The system is used with commercially available head-mounted displays.
Published
2026-01-26
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
07290016986181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290016986181072900169861817290016986181

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
07290016986167VRBehaviorVRET-910 (Expose)2024-04-09

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
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
00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
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
07290016986167VRBehaviorXR HEALTH IL LTDISD2024-04-09
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