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NYOrtho APEX CORE Pommel Wheelchair Cushion Gel-Foam 18x16x2

N.Y. ORTHOPEDIC USA, INC. · Model 9599-GP-181602 · UDI-DI 00811677013602

IMP

510(k) clearances

134

Adverse events (1 deaths)

Recalls

171

Facilities

Description

For patients requiring hip positioning, the NYOrtho APEX CORE™ Pommel Gel-Foam Cushion, combines a firm core foundation that eliminates hammocking with the superlative APEX™ innovative design that chambers the gel-pod closer to the top of the cushion providing a cooler interface between the patient and wheelchair. A high-performance stretch cover, improves moisture evaporation and enhances the APEX™ design features.

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.