IMPClass I

Cushion, Wheelchair

Physical Medicine · 21 CFR 890.3920

MDR events134All time

Recalls1All time

Registered firms173Currently listed

510(k) clearances2All time

Recent MDR events

134 adverse event reports on file

Event type breakdown

Malfunction67

Injury61

Other5

Death1

Most-reported manufacturers

Sunrise Medical (us) Llc41 Unknown16 Invacare Cleveland Street14 Invacare Taylor Street8 Sunrise Medical8 Sunrise Medical Privada Misiones4 Sunrise Medical Technologias3 Independence Technology, L.l.c.2

Recalls

1 recall events for this product code

Bock,Otto,Orthopedic Ind,Inc
TerminatedMar 21, 2014
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=S
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 flammability to the cushion after it has been washed at high temperatures. The cushions should either be returned to Otto Bock or destroyed.
Z-1266-2014 · View FDA record ↗

Registered firms

173 firms currently registered for this product code

510(k) clearances

2 clearances for this product code