510(k) Report

Devices descending from K964799

117 later devices reach Artrotherm Cryotherapy and Thernotherapy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc.200652—
+1K023231Elfcare Device, Models 314A Through 314GMediseb, Ltd.200363—
+2K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations20240—
+2K190854Therm-XZenith Technical Innovations201911—
+2K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations201812—
+2K171685Med4 EliteCool Systems, Inc. (Dba Game Ready)201721—
+2K122640VpulseCothera, LLC20130—
+2K111748Recovery+ Model PS 511, Dvtherapy Model PS 511AJoy Long20110—
+2K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc.201125—
+2K103247VascucompThermotek, Inc.20100—
+2K100969Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…Wmi Enterprises, LLC20100—
+2K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+2K070299Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc.200726—
+2K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+3K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE Saúde20260—
+3K252386Hot and Cold Compression System (A02-C-032)Chengdu Cryo-Push Medical Technology Co.,Ltd20260—
+3K242754ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)Zamar Medical D.O.O.20251—
+3K222136Cryo-Thermo Compression Device (FGK002)Suzhou Microport Rehabtech (Group) Co., Ltd.20230—
+3K193079ICE COMPRESSION FIRST, DUO, & MOOVE SystemsMks Paris20210—
+3K193550Therm-XZenith Technical Innovations202010—
+3K183702Polar Care WaveBreg, Inc.20193—
+3K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd.201725—
+3K133274Vena ProInnovamed Health, LLC201422—
+3K130174Dvtcare CA5Ossur Americas, Inc.20132—
+3K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+4K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.20260—
+4K253150Cryon-X Cold CompressionJkh Health Co., Ltd.20250—
+4K242940Xrecovery (XR-001)Shenzhen Xinrun Electric Appliances Co, Ltd.20240—
+4K240986Cold CompressionJkh Health Co., Ltd.20240—
+4K223729FLOWpressoMedella Health Limited20233—
+4K223541Cold/Hot CompressionJkh Health Co., Ltd.20232—
+4K231912Therm-XZenith Technical Innovations20231—
+4K213097Armory MotionPain Management Technologies, Inc.20220—
+4K211403HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc.20213—
+4K203310SyneCare 1000 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd.20211—
+4K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+4K200285VenaOneVena Group, LLC20201—
+4K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+4K193275Nerve and Muscle StimulatorShenzhen Xft Medical Limited20202—
+4K192733RelieforMe TENS/EMS Device Model UPK-GE01Umeheal, Ltd.20191—
+4K193020VenaPro Vascular Therapy SystemInnovamed Health, LLC20192—
+4K182671Medi-Direct TENS PenJkh USA, LLC20190—
+4K182203JKH Stimulator PlusJkh USA, LLC20197—
+4K180248VascuEase IC-1200-WHBio Compression Systems, Inc.20181—
+4K160318PlasmaFlowManamed, Inc.20164—
+4K151158ALP VasQcare Take Home SystemCurrie Medical Specialties, Inc.20150—
+4K151189Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products20155—
+4K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd.20142—
+4K090094Zeltiq SystemZeltiq Aesthetics200932—
+5K252767actiTENS miniSublimed20260—
+5K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd.20242—
+5K232270DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd.20240—
+5K223027NeuroTrigger Basic (NTB)Neurotrigger20230—
+5K232675Heating Tens, FT-615Hivox Biotek, Inc.20230—
+5K223151Nu-beca Transcutaneous Electrical Nerve StimulationNu-Beca & Maxcellent Co.20230—
+5K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+5K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+5K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—
+5K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+5K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+5K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—
+5K211937SyneCare 1100 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd.20210—
+5K212731Circul8 ProOrtho8, Inc.20210—
+5K211235CIRCUL8 Luxe DVT Prevention DeviceOrtho8, Inc.20210—
+5K211200WoundExpressHuntleigh Healthcare, Ltd.20210—
+5K211253PlasmaWaveManamed, Inc.20210—
+5K202159actiTENSSublimed20201—
+5K201431OGYILI TENS/NMES StimulatorGongguan Tutamen Metalwork Co., Ltd.20200—
+5K200353ManaFlowManamed, Inc.20201—
+5K200568B&J MHP800 Deep Vein Thrombosis (DVT) Prevention SystemB&J Manufacturing, Ltd.20200—
+5K191107PlexusAlleva Medical (D.G), Ltd.20190—
+5K191151JKH Stimulator PlusJkh USA, LLC20194—
+5K180389Venera 508 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.20181—
+5K170814Devon 24Devon Medical Products (Jiangsu), Ltd.20170—
+5K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd.20151—
+5K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+6K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…Wenzhou Lingfeng Electronic Technology Co., Ltd.20260—
+6K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…Shenzhen Future Electronic Co., Ltd.20250—
+6K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+6K240011Lymphedema CompressionJkh Health Co., Ltd.20240—
+6K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+6K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+6K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+6K183349AeroDVx SystemSun Scientific, Inc.20190—
+6K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd.20160—
+6K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+6K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+6K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+7K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—
+7K160470SculpSureCynosure, Inc.201620—
+7K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+7K150724SculpSureCynosure, Inc.201521—
+7K150230SculpSureCynosure, Inc.201521—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K190743Venus BlissVenus Concept USA, Inc.20194—
+8K171111SculpsureCynosure, Inc.201710—
+8K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+9K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+9K222226EONDominion Aesthetic Technologies, Inc.20230—