| Primary Device ID | 00810188050038 |
| NIH Device Record Key | b343c555-ffec-4930-b1fe-48137633acaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bioness Integrated System (BITS) Mobile Configuration |
| Version Model Number | BIT-2224 |
| 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 | true |
| 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 |
| 00810188050038 - Bioness Integrated System (BITS) Mobile Configuration | 2025-07-25Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Display with Software |
| 00810188050038 - Bioness Integrated System (BITS) Mobile Configuration | 2025-07-25 Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Display with Software |
| 00810188050069 - L360 Thigh System | 2025-07-25 L360 Thigh System Kit, Left |
| 00810188050076 - L300 Go System | 2025-07-25 L300 Go System, Right Lower |
| 00810188050090 - L300 Go System | 2025-07-25 L300 Go System, Right Small Lower |
| 00810188050106 - L300 Go System | 2025-07-25 L300 Go System, Left Small Lower |
| 00810188050113 - L300 Go System | 2025-07-25 L300 Go System, Right Thigh Plus |
| 00810188050137 - L300 Go System | 2025-07-25 L300 Go System, Right Thigh Stand-Alone |
| 00810188050144 - L300 Go System | 2025-07-25 L300 Go System, Left Thigh Stand-Alone |