510(k) Report

Devices descending from K881114

77 later devices reach Empi Model 989, Tens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061799Quadratens, Model QT-42Bio-Research Associates, Inc.20060—
+1K970203Epix VTEmpi199775—
+2K070474Newlife Sciences LLC, Model TMRNewlife Sciences, LLC20071—
+2K061650Select Tens, Model 4600SEmpi200756—
+2K032928Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America20032—
+2K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc.200213—
+2K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc.200114—
+3K202186TrueRelief DeviceTruerelief20210—
+3K153704StriveDjo, LLC201624—
+3K120398Witouch ProHollywog, LLC20123—
+3K120569Gemore Tens SystemGemore Technology Co, Ltd.20120—
+3K113037Pain-AidPdi Works, LLC201233—
+3K093324Empi ContinuumEmpi201026—
+3K090922Empi Active Transcutaneous Nerve StimulatorEmpi200915—
+3K081141Combocare 2000Xanacare Technologies, LLC20086—
+3K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation200612—
+4K211801SPRINT PNS SystemSpr Therapeutics, Inc.20211—
+4K182203JKH Stimulator PlusJkh USA, LLC20197—
+4K171599WiTouch Pro, WiTouch, NeubacHollywog, LLC20170—
+4K170918Compex Sport EliteDjo, LLC20174—
+4K170903Compex Wireless USADjo, LLC201710—
+4K160246SimulCare II (TM)Xanacare Technologies, LLC20160—
+4K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC20169—
+4K143430SmartTENSEasy Med Instrument Co., Ltd.20151—
+4K142025Neurolumen PN-1000Neurolumen, LLC20150—
+4K131159SmartreliefChattem, Inc.201332—
+4K124016Empi PhoenixDjo, LLC201325—
+4K121184SensusNeurometrix, Inc.201214—
+4K083822Laser TouchoneLaser Health Technologies, LLC20091—
+4K083202Combocare 2000Xanacare Technologies, LLC20082—
+4K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation200811—
+5K252767actiTENS miniSublimed20260—
+5K243782StimTrial Neuromodulation SystemBioventus, LLC20250—
+5K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.20230—
+5K212859First ReliefDyansys, Inc.20210—
+5K202159actiTENSSublimed20201—
+5K201653Compex Sport Elite 3.0Djo, LLC20202—
+5K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd.20200—
+5K182020Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20200—
+5K190966Katalyst Training SystemKatalyst, Inc.20203—
+5K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+5K191151JKH Stimulator PlusJkh USA, LLC20194—
+5K181419Flix-EmsCasgarum Investment, S.L.20190—
+5K181955WiEMSproMedical Cables S.L.20193—
+5K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—
+5K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC20177—
+5K162479Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd.20173—
+5K150043Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20151—
+5K130919SensusNeurometrix, Inc.201313—
+5K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+5K100116Lasertouchone (Otc)Laser Health Technologies, LLC20100—
+5K090866Neurocalm Model 1 and 2Neuromed Devices, Inc.20090—
+6K253636Zionic Pro Max (EMS)Termosalud S.L.20260—
+6K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.20250—
+6K233770Pepper EMS Training SystemPepper Interactive, Inc.20250—
+6K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+6K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+6K230261Gnesis EMS PlusCreative Fitness Developments S.L.20230—
+6K222386VisionbodyVb Technologies AG20230—
+6K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd.20220—
+6K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+6K211298WiEMSproMedical Cables S.L.20220—
+6K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+6K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+6K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Spr Therapeutics, Inc.20186—
+6K173462Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd.20172—
+6K143198Synapse Transcutaneous Electrical Stimulation DeviceSynapse Electroceutical Limited20150—
+6K140333AscendNeurometrix, Inc.201411—
+7K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—
+7K202660SPRINT PNS SystemSpr Therapeutics, Inc.20215—
+7K181102ThermaCare Quick Therapy TENSPfizer, Inc.20180—
+7K180331Wireless Pain Relieve DeviceShenzhen Dongdixin Technology Co., Ltd.20180—
+7K160052CUR Model 1Thimble Bioelectronics, Inc.20161—
+7K152954QuellNeurometrix, Inc.20160—
+8K233784ENSO (Model 2)Hinge Health, Inc.20240—
+8K213188Primary ReliefDyansys, Inc.20221—
+9K221425Primary ReliefDyansys, Inc.20220—