VRCBT

Basic Information

• Brand Name: VRCBT
• Primary DI: 07290016986143
• Version / Model: AT-910 (A10tion)
• Catalog Number: VRCBT AT-910
• Company Name: XR HEALTH IL LTD
• Labeler DUNS: 531893653
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-15
• Public Version: 7
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 6ca83cb2-5137-409e-abed-e021a4077705
• Distribution End Date: 2021-07-05

Device Description

The AT-910 ("A10tion") is a is a virtual reality, immersive therapeutic application, indicated to train and improve cognitive function of patients with diagnosed ADHD. This application is a clinician- monitored program and should be considered for use as part of the therapeutic program that include clinician directed therapy This multidimensional training program application targets attention, executive function and memory combined with motor activation through the use of games and entertainment features.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PTY	Computerized Cognitive Assessment Aid, Exempt	Neurology	882.1470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63031	Mental health/function therapeutic software, screen-viewed	A screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically indicate development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient which may involve clinical assistance/recommendations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016986143	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]