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AcroGrip™ Device

AXOGEN CORPORATION · Model EN-247 · UDI-DI 10850828007012

LBB
10
510(k) clearances
0
Adverse events
2
Recalls
17
Facilities

Description

Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (NSMTS) to measure grasp strength.

Recalls

DateFirmReason
2021-11-30Activbody, Inc.Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and lis
2021-11-30Activbody, Inc.Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and lis

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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.