Device Description : A software-only medical device intended to aid mitigate or assess conditions rel 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-620 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-620 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The MD-710 ("Relax8") is intended to assist in relaxation and self-management of The MD-710 ("Relax8") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The MD-710 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The MD-710 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. MD-710 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The PD-810 ("Mindset") is intended to assist in relaxation and self-management o The PD-810 ("Mindset") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation andrelaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The PD-810 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The PD-810 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplicati The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplication, indicated to train and improve cognitive function of patients withdiagnosed ADHD. This application is a clinician- monitored program and should beconsidered for use as part of the therapeutic program that include clinician directedtherapyThis multidimensional training program application targetsattention, executive function and memory combined with motor activationthrough the use of games and entertainment features.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes