Ondamed Inc recalls Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated…

Recall date

July 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1782-2018

FDA classification

Class II

Brand / firm

Ondamed Inc

Sold / distributed

Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.