| Primary Device ID | 00810188050557 |
| NIH Device Record Key | 433eb6be-f2d3-44b1-9ef5-6a98a46afb55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vector Base |
| Version Model Number | VEC-3000 |
| Company DUNS | 119378513 |
| Company Name | Bioness Medical, 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 | false |
| 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 |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com | |
| Phone | +1(800)211-9136 |
| info@bionessmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810188050557 [Primary] |
| GS1 | 00815962020283 [Previous] |
| ION | Exerciser, Non-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 | 2025-07-28 |
| Device Publish Date | 2025-07-18 |
| 00810188050014 - Vector Gait and Safety System | 2025-07-28 Vector Gait and Safety System, Elite Model |
| 00810188050021 - Bioness Integrated System (BITS) Bedside Configuration | 2025-07-28 Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software |
| 00810188050045 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance | 2025-07-28 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit |
| 00810188050052 - L360 Thigh System | 2025-07-28 L360 Thigh System Kit, Right |
| 00810188050083 - L300 Go System | 2025-07-28 L300 Go System, Left Lower |
| 00810188050120 - L300 Go System | 2025-07-28 L300 Go System, Left Thigh Plus |
| 00810188050175 - L100 Go System | 2025-07-28 L100 Go System, Left |
| 00810188050274 - L300 Go System | 2025-07-28 Quick Fit Electrode, Right |