VRCogni

GUDID 07290016986105

A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-610 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-610 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.

VR HEALTH LTD

Cognitive therapy software

• Primary Device ID: 07290016986105
• NIH Device Record Key: 8300326e-fbb3-4eb2-b48a-d97679e5ae9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VRCogni
• Version Model Number: CT-610 (Re-Act)
• Company DUNS: 531893653
• Company Name: VR HEALTH LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health
• Phone: +1 (857)-990-6111
• Email: support@xr.health

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016986105 [Primary]

FDA Product Code

• PTY: Computerized Cognitive Assessment Aid, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-06
• Device Publish Date: 2019-11-28

On-Brand Devices [VRCogni]

• 07290016986105: A software-only medical device intended to aid mitigate or assess conditions related to cognitiv
• 07290016986112: A software-only medical device intended to aid mitigate or assess conditions related to cognitiv