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TM "Rehabilitimed" K-1V L Comfort

REABILITIMED TOV · Model K-1V L Comfort · UDI-DI 04823097717844

ITQ

510(k) clearances

493

Adverse events

Recalls

454

Facilities

Description

The orthopedic device in graphite color is a detachable knee joint orthosis made of modern multilayer material with an inner layer of 100% cotton terry cloth. To enhance fixation and preserve the biomechanics of movement in the knee joint, the orthosis is reinforced with metal tires with Monocentric hinges located on the side surfaces and two parallel straps with textile fasteners in the lower third of the thigh and upper third of the shin.

Recalls

Date	Firm	Reason
2020-06-18	Mueller Sports Medicine, Inc	Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
2019-11-21	DeRoyal Industries Inc	The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
2016-02-24	Ossur H / F	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,

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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.