510(k) Report

Devices descending from K203574

4 later devices reach HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+1K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+1K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+1K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—