| Primary Device ID | 00850017250079 |
| NIH Device Record Key | a73ae03c-bef2-41c4-b738-5c50b25cab6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Balance Advantage Computerized Dynamic Posturography System |
| Version Model Number | 97P-0036 |
| Company DUNS | 619142540 |
| Company Name | BERTEC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| KHX | Platform, Force-Measuring |
| 00850017250000 - Bertec Vision Advantage | 2021-01-13 Bertec Vision Advantage (BVA) device is designed to measure changes in the visual acuity during head movements. It includes a l |
| 00850017250017 - Balance Advantage Tender Essential System | 2021-01-13 Bertec Balance Advantage Tender Essential system is a clinical balance assessment device that collects and analyzes force and mo |
| 00850017250024 - Balance Advantage Portable Functional System | 2021-01-13 Bertec Balance Advantage Portable Functional system is a clinical balance assessment device that collects and analyzes force and |
| 00850017250031 - Balance Advantage Functional System | 2021-01-13 Bertec Balance Advantage Functional system is a clinical balance assessment device that collects and analyzes force and movement |
| 00850017250048 - Balance Advantage Essential System | 2021-01-13 Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement |
| 00850017250055 - Balance Advantage Portable essential System | 2021-01-13 Bertec Balance Advantage Portable Essential system is a clinical balance assessment device that collects and analyzes force and |
| 00850017250062 - Balance Advantage Prime IVR System | 2021-01-13 Bertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement |
| 00850017250079 - Balance Advantage Computerized Dynamic Posturography System | 2021-01-13The 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. |
| 00850017250079 - Balance Advantage Computerized Dynamic Posturography System | 2021-01-13 The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force an |