Neu-Elm, DE · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Class II | Physical Medicine | 4 | 2026-01-16 |
| PBX | — | — | — | 2 | 2024-07-15 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Class II | Gastroenterology, Urology | 1 | 2023-10-05 |
| ITH | — | — | — | 1 | 2023-05-16 |
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 1 | 2022-02-04 |
| IPF | Stimulator, Muscle, Powered | Class II | Physical Medicine | 1 | 2021-02-19 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-16 | K253408 | CoolTone | NGX | Class II | Physical Medicine |
| 2025-07-14 | K251378 | CoolTone | NGX | Class II | Physical Medicine |
| 2024-07-21 | K240347 | PTG-05 | NGX | Class II | Physical Medicine |
| 2024-07-15 | K240178 | RFG-01 | PBX | — | — |
| 2023-10-05 | K230780 | MFG-05 | KPI | Class II | Gastroenterology, Urology |
| 2023-05-25 | K213256 | ThermoTK | PBX | — | — |
| 2023-05-16 | K222912 | c1Trac | ITH | — | — |
| 2022-04-01 | K220601 | CoolTone | NGX | Class II | Physical Medicine |
| 2022-02-04 | K220020 | Cryo 7 | GEX | Class II | General, Plastic Surgery |
| 2021-02-19 | K203488 | emField | IPF | Class II | Physical Medicine |