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E-LINK Myo-EX GX1 EMG Sensor

BIOMETRICS LIMITED · Model GX1 · UDI-DI 05060481692441

510(k) clearances

Adverse events

Recalls

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. GX1 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13

Recalls

Date	Firm	Reason
2015-04-09	BTE Technologies, Inc.	On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use sc
2013-12-03	MedX Holdings, Inc.	Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.

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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.