VRCBT

Primary DI
07290016986143
Brand
VRCBT
Company
XR HEALTH IL LTD
Model
AT-910 (A10tion)
Catalog number
VRCBT AT-910
Device description
"The AT-910 (""A10tion"") is a is a virtual reality, immersive therapeuticapplication, indicated to train and improve cognitive function of patients withdiagnosed ADHD. This application is a clinician- monitored program and should beconsidered for use as part of the therapeutic program that include clinician directedtherapyThis multidimensional training program application targetsattention, executive function and memory combined with motor activationthrough the use of games and entertainment features. "
Published
2021-06-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTYComputerized Cognitive Assessment Aid, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTYComputerized Cognitive Assessment Aid, ExemptNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016986143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016986143072900169861437290016986143

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive training 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, stimulating game-like activities); it is not intended for kinesiology-based neuromuscular rehabilitation and is not based on virtual reality. 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 at home, school, and in clinical settings.

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
07290016986181XRBehaviorVRFR-930 (First Resort)2026-01-26
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
03770027067016MSCopilot®AD SCIENTIAMPTY2026-04-20
07290016986198XRCogni XR HEALTH IL LTDPTY2026-02-12
00860013886127CNS Vital Signs VSCCNS Vital Signs, LLCPTY2025-09-01
05070002974673NeuroMotor PenMANUS NEURODYNAMICA LTDPTY2025-08-01
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.PTY2025-07-18
00860013886103CNS Vital Signs WebCNS Vital Signs, LLCPTY2025-07-07
00860013886110CNS Vital Signs LocalCNS Vital Signs, LLCPTY2025-07-07
00860013886134CNS Vital Signs CognitraxCNS Vital Signs, LLCPTY2025-07-07
00860000564045Cognivue ClarityCOGNIVUE, INC.PTY2025-06-12
00860000564052Cognivue ThriveCOGNIVUE, INC.PTY2025-06-12
00860011882022SPARK NeuroSpark Neuro Inc.PTY2025-05-01
G676NEUROFLEX0NeuroFlexSaccade Analytiques IncPTY2025-04-29
04262390860015neotivCareneotiv GmbHPTY2025-04-14
G134EPIO1NeuroCatch EPiONeuroCatch IncPTY2025-02-28
00860011464525CognigramCogstate Inc.PTY2025-01-18
00860011464532CognigramCogstate Inc.PTY2025-01-18
G134NCCPXS1NeuroCatch EEG CapNeuroCatch IncPTY2024-12-01
00860011464501CognigramCogstate Inc.PTY2024-08-24
00860011464518CognigramCogstate Inc.PTY2024-08-24
00860007318764Cognition Chronicle v2.1Qr8 Health IncPTY2024-07-22
B626200050Core Cognitive EvaluationLinus Health, Inc.PTY2024-06-05
00860007318788Chronicle Web v2.0Qr8 Health IncPTY2024-05-20
00860007318795Cognition Chronicle v2.0Qr8 Health IncPTY2024-05-20
00860011850922Cognition Snapshot+ v2.4Qr8 Health IncPTY2024-04-29
00860011850908MSPT v3.1.1Qr8 Health IncPTY2024-04-05
00860011850915MSPT Web v3.1.0Qr8 Health IncPTY2024-04-05
00195893329458MSPT Web v3.0Qr8 Health IncPTY2024-03-01
00195893702190MSPT v3.0Qr8 Health IncPTY2024-02-16
00860011154501BrainCheck AssessBraincheck, Inc.PTY2023-12-15
00860007318771Cognition Snapshot+ 2.3.0Qr8 Health IncPTY2023-11-01