FDA Device Intelligence
Home › BIOMETRICS LIMITED › E-LINK Hand Kit

E-LINK Hand Kit

BIOMETRICS LIMITED · Model H500 · UDI-DI 05060481690041

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

Description

The E-LINK Hand Kit which includes a Dynamometer and Pinchmeter for monitoring grip and pinch strength, is the ideal module to quantify and monitor the effectiveness of various interventions for the upper extremity, throughout the whole rehabilitation process. The Hand Kit can also be used with the E-LINK Activities (Games), for innovative isometric grip and pinch exercises that are totally focused on the individual patient. The Hand Kit (H500) is available with either a wireless or wired interface

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.