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Vrcbt

FDA UDI

Class II (US FDA UDI)

by Xr Health Il Ltd

Identity

Trade Name
VRCBT FDA UDI
Generic Name
Mental health/function therapeutic software, screen-viewed FDA UDI
Device Name
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. FDA UDI
Model / Reference
AT-910 (A10tion) FDA UDI
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. FDA UDI

Identifiers

Catalog Number
VRCBT AT-910 FDA UDI
Primary DI / UDI-DI
07290016986143 FDA UDI
FDA Product Code
PTY FDA UDI
GMDN Term
Mental health/function therapeutic software, screen-viewed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1470 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Vrcbt by Xr Health Il Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xr Health Il Ltd

Sources (1)

  • FDA UDI 6ca83cb2-5137-409e-abed-e021a4077705 36 fields · synced May 31, 2026