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E-LINK DG1 Wireless Dongle

BIOMETRICS LIMITED · Model DG1 · UDI-DI 05060481690195

ISDBXBION
10
510(k) clearances
35
Adverse events
2
Recalls
74
Facilities

Description

The wireless Dongle (DG1) enables E-LINK to be used as a complete stand-alone wireless evaluation and exercise system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

Recalls

DateFirmReason
2015-04-09BTE 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
2013-12-03MedX 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.