Drug recall
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is…
FDA recall event 79858 · Class II · Ondamed Inc
Key facts
| Event ID | 79858 |
|---|---|
| Recall numbers | Z-1782-2018 |
| Recalling firm | Ondamed Inc |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers… |
| Initiation date | Jul 7, 2017 |
| Report date | May 16, 2018 |
| Termination date | Apr 24, 2020 |
| City | New Windsor |
| State | NY |
| Country | United States |
| FEI number | 3003745260 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: