Gainesville, FL, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | Class II | Neurology | 1 | 2022-04-25 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-07-19 | Class II | Terminated | Z-1523-2022 | Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. | — | Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock. |