510(k) Report

Devices descending from K090922

15 later devices reach Empi Active Transcutaneous Nerve Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121184SensusNeurometrix, Inc.201214—
+2K130919SensusNeurometrix, Inc.201313—
+3K143198Synapse Transcutaneous Electrical Stimulation DeviceSynapse Electroceutical Limited20150—
+3K140333AscendNeurometrix, Inc.201411—
+4K182203JKH Stimulator PlusJkh USA, LLC20197—
+4K160052CUR Model 1Thimble Bioelectronics, Inc.20161—
+4K152954QuellNeurometrix, Inc.20160—
+5K252767actiTENS miniSublimed20260—
+5K233784ENSO (Model 2)Hinge Health, Inc.20240—
+5K202159actiTENSSublimed20201—
+5K191151JKH Stimulator PlusJkh USA, LLC20194—
+6K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+6K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+6K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+7K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—