Woodbridge, NJ, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | Class II | Neurology | 2 | 2024-03-25 |
| OBP | Transcranial Magnetic Stimulator | Class II | Neurology | 1 | 2026-02-20 |
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Class II | Neurology | 1 | 2024-06-03 |
| HAW | — | — | — | 1 | 2020-04-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-02-20 | K251653 | SPRY TMS Therapy System (0550) | OBP | Class II | Neurology |
| 2024-06-03 | K233751 | Milieve (YPS-301BD) | PCC | Class II | Neurology |
| 2024-03-25 | K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | GWF | Class II | Neurology |
| 2021-08-13 | K192823 | MEGA-TMS | GWF | Class II | Neurology |
| 2020-04-06 | K191422 | Neural Navigator | HAW | — | — |