FDA-Device2018-05-16Class II
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.
Ondamed Inc
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.
Sold states
Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.
Affected count
585
Manufactured in
80 Waterview Ter, N/A, New Windsor, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1782-2018Don't want to check this manually?
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