Device recall
Z-1782-2018: Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery…
FDA device recall · Class II · Ondamed Inc
Key facts
| Recall number (Z-number) | Z-1782-2018 |
|---|---|
| Recall event | 79858 |
| Product | Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use. |
| Product code | HCC |
| Recalling firm | Ondamed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2020 |
| FEI number | 3011088301 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database