510(k) Report

Devices descending from K070807

6 later devices reach Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+1K080386Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC20084—
+2K121483Reusable Cutaneous ElectrodeAmpcare, LLC20121—
+2K083756Guardian 150 ElectrodeSelectivemed Components, Inc.20093—
+3K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd.20180—
+3K113375Eswallow Usa Electrode,Eswallow Usa LeadwireEswallow USA20130—