Fairfield, NJ, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| ITX | — | — | — | 1 | 2024-08-15 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-03-22 | Class II | Ongoing | Z-1604-2024 | Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme. | — | Product demonstrates low viscosity. |
| 2024-01-22 | Class II | Ongoing | Z-1204-2024 | Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each. | — | Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. |