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Konmed

Shenzhen Konmed Technology Co., Ltd. · Model KM-F-58 · UDI-DI 06970935830505

ITW

510(k) clearances

Adverse events

Recalls

461

Facilities

Description

It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustable by customer desired with below feature: - The half-hard design at the bottom of the device and adjust and swing according to human walking habit, while the thin and soft design make it easy to wear and can help to recovery and satisfy patient’sdemand - The hollow designing on the heel part is good to wear - The cushion on the shin and shank can be disassembled, which is convenient to wash and good to maintain hygienic - With left and right design difference - The tiptoe part can be trimmed based on your size - The “8” shape straps is detachable

Recalls

Date	Firm	Reason
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
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
2015-04-13	United Surgical Associates	The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

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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.