Oberline, OH, US · 1 510(k) clearances · 1 PMAs · 2 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | Class II | Neurology | 1 | 2025-06-05 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2023-03-31 | P200018 | NeuRX Diaphragm Pacing System (DPS) | Original | OIR | Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-07-11 | Class I | Terminated | Z-1561-2022 | NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021. | — | Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potent… |
| 2022-05-31 | Class III | Terminated | Z-1393-2022 | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx … | — | Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is inten… |