FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016986181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016986181072900169861817290016986181

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (857) 990-6111Support@xr.health

Regulatory Flags#

DUNS number
531893653
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016986211XRBehaviorVRSO-940 (Step Out)2026-05-14
07290016986204XRBehaviorVRGC-940 (GameChange)2026-05-04
07290016986198XRCogni CT-630 Koji Quest2026-02-12
07290016986174XRBehaviorVRMM-920 (Mind&Motion)2026-01-26
07290016986143VRCBTAT-910 (A10tion)VRCBT AT-9102021-06-15
07290016986129VRRelieverMD-710 (Relax8)2020-01-21
07290016986112VRCogniCT-620 (Memorize)2019-12-30
07290016986105VRCogniCT-610 (Re-Act)2019-11-28
07290016986068VRRelieverCB-510 (Luna)2019-06-13
07290016986167VRBehaviorVRET-910 (Expose)2024-04-09
07290016986075VRCogniMC-320 (Color Match)2020-02-20
07290016986099VRPhysio N-140 (Rotate)2019-10-16
07290016986082VRPhysio MT-220 (Balloon Blast)2019-09-08
07290016986006VRPhysioN-110 (Aqua Clown)2018-05-01
07290016986013VRPhysioMT-210 (Balloon Blast)2018-05-01
07290016986020VRPhysioN-120 (Catch the Screen)2018-05-01
07290016986037VRPhysioP-410 (Dot Track)2018-07-18
07290016986044VRPhysioMC-310 (Color Match)2018-07-18
07290016986136VRRelieverPD-810 (Mindset)VRReliever PD-8102021-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065013876061Sword ThriveSWORD HEALTH, S.A.ISD2026-06-02
08717524641085Lode B.V.Lode B.V.ISD2026-06-01
08717524641092Lode B.V.Lode B.V.ISD2026-06-01
07649998859059NUSHUMagnes AGISD2026-05-31
07290016986211XRBehaviorXR HEALTH IL LTDISD2026-05-14
07290016986204XRBehaviorXR HEALTH IL LTDISD2026-05-04
00199874272399SeniorLife.AISENIORLIFE TECHNOLOGIES INC.ISD2026-03-11
00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006522EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
00860014763700Aspire MotionSurge Motion Inc.ISD2025-11-14
G186EXERSCAN30Exer ScanExer Labs, Inc.ISD2025-11-10
00860004615606XR Therapy SystemNeuromersive, Inc.ISD2025-10-25
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.ISD2025-07-18
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
G741WHREHABV10Waya RehabWELLOVATE, LLCISD2025-02-03
00860010613320StrideLink MercuryStrideLink Inc.ISD2024-12-16
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