510(k) Report

Devices descending from K182203

7 later devices reach JKH Stimulator Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252767actiTENS miniSublimed20260—
+1K202159actiTENSSublimed20201—
+1K191151JKH Stimulator PlusJkh USA, LLC20194—
+2K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+2K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+2K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+3K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—