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E-LINK EX2 Interface Unit for M400

BIOMETRICS LIMITED · Model EX2 · UDI-DI 05060481692465

HCC ISD BXB ION

510(k) clearances

Adverse events (1 deaths)

Recalls

109

Facilities

Description

The EX2 Interface Unit is used to connect the M400 Myo-EX (GX1, GX2) and AngleX (NC1, NC2) sensors to E3000 Serial Interface Upper Limb Exerciser. 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.