510(k) Report

Devices descending from K183631

3 later devices reach medi pneumatic compression system (pcs) – brio (Model 651) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221654medi pneumatic compression system (pcs)-genius (Model 652)Medi USA, LP20220—
+1K200353ManaFlowManamed, Inc.20201—
+2K240011Lymphedema CompressionJkh Health Co., Ltd.20240—