| Primary Device ID | 00850017250048 |
| NIH Device Record Key | 8cac9cdf-1b0f-4e6c-bf54-deebc105353d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Balance Advantage Essential System |
| Version Model Number | 97P-0001 |
| 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 |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com | |
| Phone | 1-614-543-8099 |
| support@bertec.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017250048 [Primary] |
| KHX | Platform, Force-Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-13 |
| Device Publish Date | 2021-01-05 |
| 00850017250116 - Bertec Head Mounted Display System (HMD) | 2023-02-16 Bertec Balance Advantage Head Mounted Display (HMD) system is a clinical balance assessment device that collects and analyzes fo |
| 00850017250093 - Bertec Vision Trainer System (BVT) | 2022-02-01 The Bertec Vision Trainer System (BVT) is a device that objectively measures the performance of subject’s visuo-motor skills. |
| 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 | 2021-01-13Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate. |
| 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 |