510(k) Report

Devices descending from K090308

8 later devices reach Restep Dvy System, Model RSP-101 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141578Devon Cirona 6200 DVTDevon Medical20144—
+1K130571Devon Cirona 6100 DVTDevon Medical, Inc.20136—
+1K101087Reprocessed Restep Compression SleevesAscent Heatlhcare Solutions20100—
+2K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.20250—
+2K211253PlasmaWaveManamed, Inc.20210—
+2K190975Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC20190—
+2K182578Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy DeviceDevon Medical Products (Jiangsu), Ltd.20190—
+2K131743Cirona DVT Foot GarmentDevon Medical, Inc.20130—