Recall Z-1782-2018— Ondamed Inc
Class II · Terminated
Class II FDA medical device recall by Ondamed Inc, initiated 2017-07-07, terminated 2020-04-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Ondamed Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-07
- Terminated
- 2020-04-24
- Firm location
- New Windsor, NY, United States
Product description
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.
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.