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E-LINK Hand Kit
BIOMETRICS LIMITED · Model H500 · UDI-DI 05060481690041
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
| 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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Get your free API keyRead the docsData 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.
