510(k) Report

Devices descending from K031017

18 later devices reach Sys*Stim 208 and 208A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200088g.Estim FESG.Tec Medical Engineering GmbH20200—
+1K182203JKH Stimulator PlusJkh USA, LLC20197—
+1K133638GEKOFirstkind Limited20143—
+1K053266Myotrac InfinitiThought Technology, Ltd.20054—
+2K252767actiTENS miniSublimed20260—
+2K211094Nerve and Muscle StimulatorShenzhen Xft Medical Limited20210—
+2K202159actiTENSSublimed20201—
+2K191151JKH Stimulator PlusJkh USA, LLC20194—
+2K152677geko T-2 Neuromuscular StimulatorFirstkind Limited20152—
+2K070425Vitalstim ExperiaChattanooga Group20072—
+3K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+3K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+3K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+3K163125geko™ T-2 and geko™ Plus R-2 Neuromuscular StimulatorsFirstkind Limited20170—
+3K160299geko (TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited20161—
+3K153224VitalStim (R) Plus Electrotherapy SystemDjo, LLC20160—
+3K120922Guardian Dysphagia Dual Channel Nmes UnitSelectivemed Components, Inc.20130—
+4K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—