Device Description : A software-only medical device intended for cervical region rehabilitation. The A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A software-only medical device intended for upper extremity and full body rehabi A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A software-only medical device intended for cervical region rehabilitation. The A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A software-only medical device intended for cervical region and upper body extre A software-only medical device intended for cervical region and upper body extremities rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A software-only medical device intended for upper extremity and full body conven A software-only medical device intended for upper extremity and full body conventional rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes and physical discomfort through distraction and supporting exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The CB-510 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The CB-510 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. CB-510 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 : A software-only medical device intended for motor-cognitive rehabilitation. The A software-only medical device intended for motor-cognitive rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines. The MC-320 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MC-320 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 : A software-only medical device intended for upper extremity and full body rehabi A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The MT-220 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MT-220 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 : A software-only medical device intended for cervical region rehabilitation. The A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 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 : 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-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.
Device Class : 2
Duns Number: 531893653
Premarket Exempt : Yes
Prescription Use : Yes