510(k) Report

Devices descending from K162517

25 later devices reach Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211403HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc.20213—
+1K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+1K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+1K193275Nerve and Muscle StimulatorShenzhen Xft Medical Limited20202—
+1K192733RelieforMe TENS/EMS Device Model UPK-GE01Umeheal, Ltd.20191—
+1K182671Medi-Direct TENS PenJkh USA, LLC20190—
+1K182203JKH Stimulator PlusJkh USA, LLC20197—
+2K252767actiTENS miniSublimed20260—
+2K223027NeuroTrigger Basic (NTB)Neurotrigger20230—
+2K232675Heating Tens, FT-615Hivox Biotek, Inc.20230—
+2K223151Nu-beca Transcutaneous Electrical Nerve StimulationNu-Beca & Maxcellent Co.20230—
+2K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+2K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+2K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—
+2K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+2K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+2K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—
+2K202159actiTENSSublimed20201—
+2K201431OGYILI TENS/NMES StimulatorGongguan Tutamen Metalwork Co., Ltd.20200—
+2K191151JKH Stimulator PlusJkh USA, LLC20194—
+3K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+3K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+3K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+3K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+4K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—