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microfet2

Hoggan Scientific L.L.C. · Model 5021 · UDI-DI 00850002429008

510(k) clearances

Adverse events

Recalls

Facilities

Description

microFET®2 is a hand-held dynamometer (HHD) for performing muscle tests to quantitatively measure muscle weakness caused by injury, as well as measure general muscle strength. The device is used to convey an individual’s ability to resist force for a specific muscle or muscle group being tested.

Recalls

Date	Firm	Reason
2021-11-30	Activbody, 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
2021-11-30	Activbody, 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.