510(k) Report

Devices descending from K130919

13 later devices reach Sensus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143198Synapse Transcutaneous Electrical Stimulation DeviceSynapse Electroceutical Limited20150—
+1K140333AscendNeurometrix, Inc.201411—
+2K182203JKH Stimulator PlusJkh USA, LLC20197—
+2K160052CUR Model 1Thimble Bioelectronics, Inc.20161—
+2K152954QuellNeurometrix, Inc.20160—
+3K252767actiTENS miniSublimed20260—
+3K233784ENSO (Model 2)Hinge Health, Inc.20240—
+3K202159actiTENSSublimed20201—
+3K191151JKH Stimulator PlusJkh USA, LLC20194—
+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—
+5K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—