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NYOrtho SureChek Wheelchair Cushion Foam 18x16x2

N.Y. ORTHOPEDIC USA, INC. · Model 93-95-181602 · UDI-DI 00811677014104

IMP

510(k) clearances

136

Adverse events (1 deaths)

Recalls

171

Facilities

Description

NYOrtho offers our customers to upgrade any cushion to a Sure-Chek® brand medical fabric that are the original health care fabrics that were patented for use as protective covering fabrics in medical environments. Developed in cooperation with healthcare professionals, Sure-Chek® was designed to provide surface protection that is comfortable, safe, durable, and effective for use in health care facilities.

Recalls

Date	Firm	Reason
2014-01-31	Bock,Otto,Orthopedic Ind,Inc	Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers. During internal testing, it was discovered that there is a small risk of fl

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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.