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TM "Rehabilitimed" K-1-PSH S-M Comfort

REABILITIMED TOV · Model K-1-PSH S-M Comfort · UDI-DI 04823097721353

ITQ
10
510(k) clearances
493
Adverse events
12
Recalls
453
Facilities

Description

The orthopedic device is graphite in color, has a dense structure, is a knee joint orthosis made of aeroprene (aeroprene is a soft, breathable, highly elastic neoprene that has additional perforations over the entire surface, which enhances air and moisture exchange). Equipped with two lateral biomechanical stiffening ribs that provide a strong degree of fixation, lateral stabilization and relief of the knee joint. A silicone roller-ring sewn inside the knee pad stabilizes the kneecap in an anatomically correct position, reduces pain and provides additional protection of the joint from the front.

Recalls

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