510(k) K121106

TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET by Surgical Appliance Industries, Inc. — Product Code DWL

K121106 is an FDA 510(k) premarket notification submitted by Surgical Appliance Industries, Inc. for the device "TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET". The FDA issued a decision of Substantially Equivalent on April 27, 2012. The device falls under product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)), a Class II device regulated under 21 CFR 880.5780. Surgical Appliance Industries, Inc. has at least 8 other 510(k) clearances on record.