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Ondamed Inc recalls Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicat
Recalled May 16, 2018 · FDA recall Z-1782-2018 · Ondamed
Hazard
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. · FDA Class II
Units
585
Sold at
Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.
Description
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.
Manufacturer(s)
Ondamed Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →