Class II — Ondamed Inc
| Recalling firm | Ondamed Inc. |
|---|---|
| Registered facility | ONDAMED INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2. |
| 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. |
| Quantity | 585 |
| Distribution | Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan. |
| Initiated | 2017-07-07 |
| Classified | 2018-05-10 |
| Terminated | 2020-04-24 |
| Recall number | Z-1782-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ondamed Inc (Z-1782-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79858/
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