510(k) Report

Devices descending from K880235

19 later devices reach Intelect Model 120 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031017Sys*Stim 208 and 208AMettler Electronics Corp.200318—
+2K200088g.Estim FESG.Tec Medical Engineering GmbH20200—
+2K182203JKH Stimulator PlusJkh USA, LLC20197—
+2K133638GEKOFirstkind Limited20143—
+2K053266Myotrac InfinitiThought Technology, Ltd.20054—
+3K252767actiTENS miniSublimed20260—
+3K211094Nerve and Muscle StimulatorShenzhen Xft Medical Limited20210—
+3K202159actiTENSSublimed20201—
+3K191151JKH Stimulator PlusJkh USA, LLC20194—
+3K152677geko T-2 Neuromuscular StimulatorFirstkind Limited20152—
+3K070425Vitalstim ExperiaChattanooga Group20072—
+4K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+4K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+4K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+4K163125geko™ T-2 and geko™ Plus R-2 Neuromuscular StimulatorsFirstkind Limited20170—
+4K160299geko (TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited20161—
+4K153224VitalStim (R) Plus Electrotherapy SystemDjo, LLC20160—
+4K120922Guardian Dysphagia Dual Channel Nmes UnitSelectivemed Components, Inc.20130—
+5K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—