VRReliever

Primary DI
07290016986068
Brand
VRReliever
Company
XR HEALTH IL LTD
Model
CB-510 (Luna)
Device description
"The CB-510 (""Luna"") is intended to assist in the mitigation of pain, hot flashes and physical discomfort through distraction and supporting exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The CB-510 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The CB-510 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. CB-510 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment."
Published
2019-06-13
Public version status
Update
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
07290016986068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016986068072900169860687290016986068

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive therapy softwareA software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen interactive sessions (e.g., text for audible reading); it is not intended to detect/display a patient’s physical movements/actions. It may additionally be designed to screen for cognitive disorders, set baselines, and will typically show development (i.e., interactive). It is intended to be used by parents, educators, specialists and medical professionals at home, school or in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

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

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
07290016986181XRBehaviorVRFR-930 (First Resort)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
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
07290016986181XRBehaviorXR 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