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Biometrics Ltd Dynamometer

BIOMETRICS LIMITED · Model G100 · UDI-DI 05060481692403

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Biometrics Dynamometer utilises precision load cell technology to increase the sensitivity and accuracy of measurement of even very low grip strength forces. 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.