510(k) Report

Devices descending from K172809

2 later devices reach OTC Combo TENS/EMS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual…Well-Life Healthcare Limited20240—
+1K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—