KINVENT

KINVENT HELLAS · Model Muscle Controller V2R01 · UDI-DI 03770011995103

510(k) clearances

Adverse events

Recalls

Facilities

Description

Muscle Controller is a hand held dynamometer used for the evaluation of muscles strength. You can assess isometric strength by the way of the peak force as well as of the average force for a specific muscle or muscle groups.The Muscle Controller allows to quantitatively measure the muscle strength and the deficit percentage caused by injury compared to the strength of the healthy side

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.