510(k) Report

Devices descending from K941577

118 later devices reach Dynatron 550 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031329Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Dynatronics Corp.200337—
+1K981976Acutron Mentor Model 961Microcurrent Research, Inc.199879—
+2K120835Dynatron Thermostim Probe-DoneDynatronics Corporation20121—
+2K113250Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light ProbeDynatronics Corp.20120—
+2K062256HF54 Combination Ultrasound Interferential and Premodulated Stimulation SystemHill Laboratories Co.20072—
+2K051680Dynatron DX2 Traction UnitDynatronics Corp.20050—
+2K051261Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light ProbeDynatronics Corp.20051—
+2K043586Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp.200513—
+2K040729Solaris D890 Therapy ProbeDynatronics Corp.200428—
+2K990787TRIO 300Ito Co., Ltd.199978—
+3K132057Dynatron Peltier Thermostim ProbeDynatronics Corp.20140—
+3K113017Sys*Stim 240Mettler Electronics Corp.20129—
+3K072256HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with…Hill Laboratories Co.20081—
+3K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+3K053201Curae'lase CL1000 IR Laser SystemCurae'Lase, Inc.20050—
+3K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+3K052182Shian Jia Meei Two Channel Digital T.E.N.S.Shian Jia Meei Enterprise Co., Ltd.200527—
+3K050070K-Laser, Models 3,4,4D,6DEltech S.R.L200512—
+3K023231Elfcare Device, Models 314A Through 314GMediseb, Ltd.200363—
+3K013167MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC200213—
+4K223802accufitMettler Electronics Corporation20235—
+4K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC20231—
+4K212618iRelieve Microcurrent Pain Relief SystemFast Track Technologies, Inc.20220—
+4K151995Painmaster MCT PatchNewmark, Inc.20160—
+4K150466ZX2 Laser SystemLzr7, Inc.20150—
+4K132529Gallieon-1 Medical LaserFuture Device and Technology, Inc.20140—
+4K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc.20130—
+4K090250Electro-Light TherapyHill Laboratories Co.20100—
+4K091497K-Laser K-1200, Model 12 WEltech S.R.L20097—
+4K090042Painmaster MCT PatchNewmark, Inc.200911—
+4K083560Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc.20081—
+4K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+4K070299Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc.200726—
+4K070400LC Therapy, Model LCT-1000Litecure, LLC20078—
+4K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+4K061656Laser-D68Laser Pain Clinics LP20065—
+5K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati20260—
+5K233926accufitMettler Electronics Corporation20244—
+5K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd.201725—
+5K151034PainKARETriowave Technologies20150—
+5K141564Opton ProZimmer Medizinsystems GmbH20140—
+5K130114Painmaster MCT PatchNewmark, Inc.20135—
+5K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC20124—
+5K120604K-LaserEltech S.R.L20124—
+5K103511Litecure Therapy SystemLitecure, LLC20110—
+5K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K251594truFlexSyrma Johari Medtech Limited20250—
+6K241685SofWave SystemSofwave Medical, Ltd.20242—
+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—
+6K171087AXON IR Heat LampCrystal Medtech, LLC20170—
+6K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+6K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+6K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC20152—
+6K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC20150—
+6K133789Dolphin Neurostim OtcAcumed Medical, Ltd.20151—
+6K1335025000Z Firefly SystemPrizm Medical, Inc.20140—
+6K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K252767actiTENS miniSublimed20260—
+7K250146SofWave SystemSofwave Medical, Ltd.20251—
+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—
+8K251746Pure ImpactSofwave Medical, Ltd.20250—
+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—