510(k) Report

Devices descending from K061650

56 later devices reach Select Tens, Model 4600S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153704StriveDjo, LLC201624—
+1K120398Witouch ProHollywog, LLC20123—
+1K120569Gemore Tens SystemGemore Technology Co, Ltd.20120—
+1K113037Pain-AidPdi Works, LLC201233—
+1K093324Empi ContinuumEmpi201026—
+1K090922Empi Active Transcutaneous Nerve StimulatorEmpi200915—
+1K081141Combocare 2000Xanacare Technologies, LLC20086—
+2K182203JKH Stimulator PlusJkh USA, LLC20197—
+2K171599WiTouch Pro, WiTouch, NeubacHollywog, LLC20170—
+2K170918Compex Sport EliteDjo, LLC20174—
+2K170903Compex Wireless USADjo, LLC201710—
+2K160246SimulCare II (TM)Xanacare Technologies, LLC20160—
+2K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+2K142025Neurolumen PN-1000Neurolumen, LLC20150—
+2K131159SmartreliefChattem, Inc.201332—
+2K124016Empi PhoenixDjo, LLC201325—
+2K121184SensusNeurometrix, Inc.201214—
+2K083822Laser TouchoneLaser Health Technologies, LLC20091—
+2K083202Combocare 2000Xanacare Technologies, LLC20082—
+3K252767actiTENS miniSublimed20260—
+3K202159actiTENSSublimed20201—
+3K201653Compex Sport Elite 3.0Djo, LLC20202—
+3K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd.20200—
+3K182020Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20200—
+3K190966Katalyst Training SystemKatalyst, Inc.20203—
+3K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+3K191151JKH Stimulator PlusJkh USA, LLC20194—
+3K181419Flix-EmsCasgarum Investment, S.L.20190—
+3K181955WiEMSproMedical Cables S.L.20193—
+3K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—
+3K162479Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd.20173—
+3K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20151—
+3K130919SensusNeurometrix, Inc.201313—
+3K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+3K100116Lasertouchone (Otc)Laser Health Technologies, LLC20100—
+4K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+4K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+4K233770Pepper EMS Training SystemPepper Interactive, Inc.20250—
+4K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+4K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+4K230261Gnesis EMS PlusCreative Fitness Developments S.L.20230—
+4K222386VisionbodyVb Technologies AG20230—
+4K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20220—
+4K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+4K211298WiEMSproMedical Cables S.L.20220—
+4K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+4K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+4K173462Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd.20172—
+4K143198Synapse Transcutaneous Electrical Stimulation DeviceSynapse Electroceutical Limited20150—
+4K140333AscendNeurometrix, Inc.201411—
+5K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—
+5K181102ThermaCare Quick Therapy TENSPfizer, Inc.20180—
+5K180331Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd.20180—
+5K160052CUR Model 1Thimble Bioelectronics, Inc.20161—
+5K152954QuellNeurometrix, Inc.20160—
+6K233784ENSO (Model 2)Hinge Health, Inc.20240—