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Spex Seating

SPEX LIMITED · Model 1102-1012-WSS-FI · UDI-DI 09420051799752

IMP
2
510(k) clearances
134
Adverse events (1 deaths)
1
Recalls
171
Facilities

Description

Wonderseat Constructa Cushion Foam Unit, 10" Wide x 12" Deep, SuperHigh Contour

Recalls

DateFirmReason
2014-01-31Bock,Otto,Orthopedic Ind,IncOtto 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.