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microfet3

Hoggan Scientific L.L.C. · Model 5026 · UDI-DI 00850002429312

510(k) clearances

Adverse events

Recalls

Facilities

Description

The microFET®3 is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury or disease, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle or muscle group being tested. Range of motion tests to quantitatively measure the angle of the body segment or joint tested to determine an individual's range of motion referenced from body's natural position.

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.