510(k) Report

Devices descending from K190347

8 later devices reach HIVOX OTC Electrical Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242460Progenix Select StimProgenix, LLC20250—
+1K200694Perfect EMSTenscare, Ltd.20211—
+1K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+2K230926Ova+ (K-OVAP-USA)Tenscare, Ltd.20230—
+2K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+2K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+2K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+2K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—