| Primary Device ID | 00850008449710 |
| NIH Device Record Key | d0cce7f5-0cb0-4984-be08-4ebc01446824 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ergostyle FX |
| Version Model Number | ES5820 |
| Company DUNS | 826316098 |
| Company Name | PIVOTAL HEALTH SOLUTIONS, INC. |
| 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 |