DEVICE: VRCBT (07290016986143)
Device Identifier (DI) Information
VRCBT
AT-910 (A10tion)
Not in Commercial Distribution
VRCBT AT-910
XR HEALTH IL LTD
AT-910 (A10tion)
Not in Commercial Distribution
VRCBT AT-910
XR HEALTH IL LTD
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
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PTY | Computerized Cognitive Assessment Aid, Exempt |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6ca83cb2-5137-409e-abed-e021a4077705
August 03, 2023
7
June 15, 2021
August 03, 2023
7
June 15, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 (857)-990-6111
support@xr.health
support@xr.health