# FDA recall Z-1782-2018

> **Ondamed Inc** · Class II · device recall initiated 2017-07-07.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1782-2018
- **Recalling firm:** Ondamed Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-07
- **Report date:** 2018-05-16
- **Termination date:** 2020-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Windsor, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1782-2018

## Citation

> AI Analytics. FDA recall Z-1782-2018. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1782-2018. Source: US FDA. Licensed CC0.

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