510(k) Report

Devices descending from K080386

4 later devices reach Columbia 600 Electrode, Columbia 06 Leadwire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121483Reusable Cutaneous ElectrodeAmpcare, LLC20121—
+1K083756Guardian 150 ElectrodeSelectivemed Components, Inc.20093—
+2K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd.20180—
+2K113375Eswallow Usa Electrode,Eswallow Usa LeadwireEswallow USA20130—