510(k) Report

Devices descending from K080661

2 later devices reach Models Tens 7000, Ems 7500 and Twin Stim through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123642Muscle Stimulation SystemNiveus Medical, Inc.20131—
+2K150742Muscle Stimulation System 110Niveus Medical, Inc.20150—