510(k) K212909

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips by Macromedics BV — Product Code IYE

K212909 is an FDA 510(k) premarket notification submitted by Macromedics BV for the device "VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips". The FDA issued a decision of Substantially Equivalent on May 11, 2022. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Macromedics BV has at least 4 other 510(k) clearances on record.