Recall Z-1782-2018 ยท HCC Device, Biofeedback
Ondamed Inc
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.
| Date | Jul 7, 2017 |
| 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. |
| Root cause | No Marketing Application |
| Action | On July 7, 2017, the firm notified affected customers that the firm had made design changes to the Ondamed Biofeedback System. Customers were asked to contact the firm as soon as possible to make arrangements to return their devices for upgrade. Customers may contact the firm at 1-845-534-0456, or by email at support@ondamed.net. For further questions, please call (845) 496-6673. |
| Quantity | 585 |
| Distribution | Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.