Device Description : Bertec Vision Advantage (BVA) device is designed to measure changes in the visua Bertec Vision Advantage (BVA) device is designed to measure changes in the visual acuity during head movements. It includes a laptop computer with a wireless remote controller, a wireless inertial measurement unit (IMU) that measures the 3-dimensional angles, velocities, and accelerations, and a headband. The headband holds the IMU in a small pouch, which allows tracking of the head movements. The remote controller is used to input the patient’s responses to the computer.
Device Class : 1
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : No
Device Description : Bertec Balance Advantage Tender Essential system is a clinical balance assessmen Bertec Balance Advantage Tender Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate
Device Class : 1
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : No
Device Description : Bertec Balance Advantage Portable Functional system is a clinical balance assess Bertec Balance Advantage Portable Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
Device Class : 1
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : No
Device Description : Bertec Balance Advantage Functional system is a clinical balance assessment devi Bertec Balance Advantage Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
Device Class : 1
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : No
Device Description : Bertec Balance Advantage Essential system is a clinical balance assessment devic Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
Device Class : 1
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : No
Device Description : Bertec Balance Advantage Portable Essential system is a clinical balance assessm Bertec Balance Advantage Portable Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
Device Class : 1
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : No
Device Description : Bertec Balance Advantage Prime IVR system is a clinical balance assessment devic Bertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Immersive Virtual Reality (IVR) to enhance clinical balance assessment and training.
Device Class : 1
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Computerized Dynamic Posturography (CDP ) system is a clinical balance asses The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
Device Class : 1
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Bertec Vision Trainer System (BVT) is a device that objectively measures the The Bertec Vision Trainer System (BVT) is a device that objectively measures the performance of subject’s visuo-motor skills. It consists of a large touchscreen monitor, a force plate, and the BVT software. The subject interacts with the screen by touching and/or moving their center of pressure in response to a target stimulus, both dynamic and static.
Device Class : 2
Duns Number: 619142540
Premarket Exempt : Yes
Prescription Use : Yes