bertec.comEYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
BERTEC CORP.
BERTEC CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1530895 | 1000480800 | BERTEC CORP. | 1 | N | 2026-01-01 | 2500 Citygate Drive COLUMBUS OH US 43219 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850017250000 | Bertec Vision Advantage - 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. | 1-614-543-8099 | support@bertec.com |
| 00850017250017 | Balance Advantage Essential Spark System - Bertec Balance Advantage Essential Spark system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate. | 1-614-543-8099 | support@bertec.com |
Registered Device Listings#
| Registration key | Listing key |
|---|---|
| 54885 | 1088576018 |
| 54885 | 1177555663 |
| 54885 | 1495690910 |
| 54885 | 1550508137 |
| 54885 | 1729868392 |
| 54885 | 1944772727 |
PMN#
FLH1768M SERIES HOSPITAL BED
BERTEC MEDICAL, INC.
GUDID#
Balance Advantage Essential Spark System - Bertec Balance Advantage Essential Spark system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
2021-01-05
Balance Advantage Functional System - Bertec Balance Advantage Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
2021-01-05
Bertec Head Mounted Display System (HMD) - Bertec Balance Advantage Head Mounted Display (HMD) system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Head Mounted Display (HMD) to enhance clinical balance assessment and training.
2023-02-08
Bertec Vision Trainer System (BVT) - 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.
2022-01-24
Bertec Vision Advantage - 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.
2021-01-05
Balance Advantage Portable Functional System - 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.
2021-01-05
Balance Advantage Essential System - Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
2021-01-05
Balance Advantage Portable essential System - 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.
2021-01-05
Balance Advantage Prime IVR System - 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.
2021-01-05
Balance Advantage Computerized Dynamic Posturography System - 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.
2021-01-05