510(k) Report

Devices descending from K071951

14 later devices reach Comfy Series: EV-804, EV-805 & EV-806 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112288Jiajian TensWuxi Jiajian Medical Instrument Co., Ltd.20123—
+1K082514Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd.20086—
+1K080661Models Tens 7000, Ems 7500 and Twin StimKoalaty Products, Inc.20082—
+2K202893Transcutaneous Electrical Nerve StimulatorWuxi Jiajian Medical Instrument Co., Ltd.20212—
+2K123642Muscle Stimulation SystemNiveus Medical, Inc.20131—
+2K092448Hivox Electric Stimulator Tens & Ems, HD2Hivox Biotek, Inc.20100—
+2K100117LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems StimulatorShenzhen Dongdixin Technology Co., Ltd.20104—
+3K220578Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)Bozhou Rongjian Medical Appliance Co., Ltd.20221—
+3K150742Muscle Stimulation System 110Niveus Medical, Inc.20150—
+3K102014Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc.20103—
+4K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)Wuxi Jiajian Medical Instrument Co., Ltd.20230—
+4K133779CP Relief WandMid-America Medical Innovations, LLC20141—
+4K113544Electronic Pulse Massager Tens Electronic Pulse MassagerProspera Corporation20120—
+5K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC20250—