510(k) Report

Devices descending from K211403

3 later devices reach HIVOX OTC Electrical Stimulator, FT610-B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232675Heating Tens, FT-615Hivox Biotek, Inc.20230—
+1K223151Nu-beca Transcutaneous Electrical Nerve StimulationNu-Beca & Maxcellent Co.20230—
+1K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—