VRCogni

XR HEALTH IL LTD · Model CT-610 (Re-Act) · UDI-DI 07290016986105

PTY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.