510(k) Report

Devices descending from K912178

89 later devices reach Bio Tens 601, 606 and 608 (3000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972244NT2000Bio-Medical Research, Ltd.199880—
+1K961376Smart-Tens, Model 456Bio-Medical Research, Ltd.19967—
+2K050595FT2000 Sequencer for Muscle StimulatorMidwest Development20050—
+2K023916BMR Neurotech Back Tens and Lumbar Support Device. Type 294Bio-Medical Research, Ltd.20040—
+2K023913Neurotech Baxolve Type 294Bio-Medical Research, Ltd.20035—
+2K990787TRIO 300Ito Co., Ltd.199978—
+3K082190Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298Bio-Medical Research, Ltd.20094—
+3K052182Shian Jia Meei Two Channel Digital T.E.N.S.Shian Jia Meei Enterprise Co., Ltd.200527—
+3K023231Elfcare Device, Models 314A Through 314GMediseb, Ltd.200363—
+3K013167MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC200213—
+4K212618iRelieve Microcurrent Pain Relief SystemFast Track Technologies, Inc.20220—
+4K151995Painmaster MCT PatchNewmark, Inc.20160—
+4K112934Neurotech RecoveryBio-Medical Research, Ltd.20120—
+4K091317Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd.20092—
+4K090042Painmaster MCT PatchNewmark, Inc.200911—
+4K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+4K070299Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc.200726—
+4K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd.201725—
+5K151034PainKARETriowave Technologies20150—
+5K130114Painmaster MCT PatchNewmark, Inc.20135—
+5K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC20124—
+5K102614Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd.20110—
+5K092793Modification to:Kneehab XP Conductive Garment, Model 411Bio-Medical Research, Ltd.20090—
+5K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K211403HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc.20213—
+6K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+6K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+6K193275Nerve and Muscle StimulatorShenzhen Xft Medical Limited20202—
+6K192733RelieforMe TENS/EMS Device Model UPK-GE01Umeheal, Ltd.20191—
+6K182671Medi-Direct TENS PenJkh USA, LLC20190—
+6K182203JKH Stimulator PlusJkh USA, LLC20197—
+6K182267PAT (Pain Alleviation Technologies)Marchan Medical, LLC20190—
+6K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC20152—
+6K133789Dolphin Neurostim OtcAcumed Medical, Ltd.20151—
+6K1335025000Z Firefly SystemPrizm Medical, Inc.20140—
+6K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K252767actiTENS miniSublimed20260—
+7K223027NeuroTrigger Basic (NTB)Neurotrigger20230—
+7K232675Heating Tens, FT-615Hivox Biotek, Inc.20230—
+7K223151Nu-beca Transcutaneous Electrical Nerve StimulationNu-Beca & Maxcellent Co.20230—
+7K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+7K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+7K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—
+7K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+7K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+7K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—
+7K202159actiTENSSublimed20201—
+7K201431OGYILI TENS/NMES StimulatorGongguan Tutamen Metalwork Co., Ltd.20200—
+7K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited20190—
+7K191151JKH Stimulator PlusJkh USA, LLC20194—
+7K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC20180—
+7K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+8K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+8K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+8K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+8K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+8K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+8K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+8K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+9K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—
+9K160470SculpSureCynosure, Inc.201620—
+9K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+9K150724SculpSureCynosure, Inc.201521—
+9K150230SculpSureCynosure, Inc.201521—
+10K211681EONDominion Aesthetic Technologies, Inc.20221—
+10K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+10K190743Venus BlissVenus Concept USA, Inc.20194—
+10K171111SculpsureCynosure, Inc.201710—
+10K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+11K222226EONDominion Aesthetic Technologies, Inc.20230—
+11K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+11K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+11K212331BodySculpRohrer Aesthetics, LLC20211—
+11K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+11K192970SlimusHironic Co., Ltd.20200—
+11K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+11K171992SculpSureCynosure, Inc.20178—
+11K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+12K233099GladiatorRohrer Aesthetics, LLC20240—
+12K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+12K231971Deka Physiq 360El.En S.P.A.20230—
+12K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+12K182741SculpSureCynosure20195—
+12K172144CoolSculpting SystemZeltiq Aesthetics20177—
+13K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+13K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805