510(k) K101614

HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 by Dm Systems, Incorporated — Product Code DWL

K101614 is an FDA 510(k) premarket notification submitted by Dm Systems, Incorporated for the device "HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809". The FDA issued a decision of Substantially Equivalent on January 13, 2011. 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.