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E-LINK Myo-EX GX3 EMG Sensor

BIOMETRICS LIMITED · Model GX3 · UDI-DI 05060481690508

HCC ISD

510(k) clearances

Adverse events (1 deaths)

Recalls

108

Facilities

Description

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX3 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. Metal connector for use with E-LINK X4 MkI or MkII Interface Unit with metal connectors. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13

Recalls

Date	Firm	Reason
2023-12-11	RONAN MEDICAL LLC	Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
2017-07-07	Ondamed Inc	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
2015-10-01	Powers Medical Devices, LLC	PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
2012-11-15	EEG Info	EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.