| Primary Device ID | 00810188050595 |
| NIH Device Record Key | f0b7df45-6d93-4982-92ca-e261802d121c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | L300 Go System |
| Version Model Number | LG4-SW01 |
| Company DUNS | 119378513 |
| Company Name | Bioness Medical, 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810188050595 [Primary] |
| GS1 | 00815962020061 [Previous] |
| GZI | Stimulator, Neuromuscular, External Functional |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-25 |
| Device Publish Date | 2025-07-17 |
| 00810188050595 | Clinician Programmer Software for L300 Go System |
| 00810188050342 | Hydrogel Electrode Set |
| 00810188050335 | Small Quick Fit Electrodes - B |
| 00810188050328 | Small Quick Fit Electrodes - A |
| 00810188050311 | Small Hydrogel Electrodes, 36mm |
| 00810188050304 | Small Round Cloth Electrodes, 36mm |
| 00810188050298 | Round Cloth Electrodes, 45mm |
| 00810188050281 | Quick Fit Electrode, Left |
| 00810188050267 | Steering Cloth Electrode, Left |
| 00810188050250 | Steering Cloth Electrode, Right |
| 00810188050243 | Thigh Cloth Electrode Set, Offset |
| 00810188050236 | Thigh Cloth Electrode Set, Centered |
| 00810188050144 | L300 Go System, Left Thigh Stand-Alone |
| 00810188050137 | L300 Go System, Right Thigh Stand-Alone |
| 00810188050113 | L300 Go System, Right Thigh Plus |
| 00810188050106 | L300 Go System, Left Small Lower |
| 00810188050090 | L300 Go System, Right Small Lower |
| 00810188050076 | L300 Go System, Right Lower |
| 00810188050274 | Quick Fit Electrode, Right |
| 00810188050120 | L300 Go System, Left Thigh Plus |
| 00810188050083 | L300 Go System, Left Lower |