Recall Z-1782-2018 — 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.
U.S. FDA — Device Enforcement · United States · 2017-07-07 · Class II
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Reported risk: 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.
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