| Primary Device ID | 00864021000322 |
| NIH Device Record Key | b40751e1-46b3-4a59-acc0-f62dc8d09e2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyoVision FlexVision Inclinometers |
| Version Model Number | D5 |
| Catalog Number | D5 |
| Company DUNS | 362997926 |
| Company Name | PRECISION BIOMETRICS INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00864021000322 [Primary] |
| KQX | Goniometer, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-15 |
| 10853818007504 - USB C Adapter | 2024-09-11 PB-210-1, USB C to A adapter |
| 00853818007491 - USB A to C Cable | 2024-09-11 PB-209, USB A to C cable |
| 00853818007507 - USB C to C Cable | 2024-09-11 PB-210, USB C to C cable |
| 00853818007477 - MyoVision Software | 2022-11-18 Software |
| 00853818007460 - MyoVision Wirefree System | 2021-05-25 VisionHUB with DynaVision Dynamic sEMG |
| 00853818007422 - SERIES-5 MyoVision Full System | 2021-03-08 VisionHub with FlexVision Inclinometers, DynaVision Dynamic sEMG and ScanVision Static sEMG Scanner |
| 00853818007439 - SERIES-5 MyoVision ScanVision | 2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanner |
| 00853818007446 - SERIES-5 MyoVision ScanVision | 2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanners |