510(k) Report

Devices descending from K000947

3 later devices reach Ultrastim Electrode, Model US4040 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131720Hivox Self Adhesive Electrode Gel PadsHivox Biotek, Inc.20140—
+1K102786Well-Life Otc Ems SystemWell-Life Healthcare Limited20110—
+1K090951RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back Conductive…Rs Medical200901