IPYClass I

Orthosis, Lumbo-sacral

Physical Medicine · 21 CFR 890.3490

MDR events10All time

Recalls1All time

Registered firms190Currently listed

510(k) clearances11All time

Recent MDR events

10 adverse event reports on file

Event type breakdown

Injury6

Malfunction2

Other2

Most-reported manufacturers

Deroyal Industries, Inc.3 Backjoy Core1 Deroyal Industries, Inc1 Deroyal Intercontinental, S.r.l.1 Medisol Usa, Inc.1 Nemectron Gmbh1 Rs Medical1 Spinecor1

Recalls

1 recall events for this product code

Ossur H / F
TerminatedUnknown
Back Support Suspenders Clip on Black
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
Z-1293-2016 · View FDA record ↗

Registered firms

190 firms currently registered for this product code

510(k) clearances

11 clearances for this product code