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Aspen Wearable Thoraco-Lumbar Pelvic Sitting Support Orthosis

Aspen Seating LLC · Model ASOW-TLPW · UDI-DI 00850032423182

IMP
2
510(k) clearances
136
Adverse events (1 deaths)
1
Recalls
171
Facilities

Description

Wearable device that protects skin while outside wheelchair (sitting on ground, other hard surfaces, etc)

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.