510(k) Report

Devices descending from K983097

8 later devices reach Tens/Fes/Nmes Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070807Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc.20076—
+1K041902Mantra ElectrodeMantra Intl. (Hk), Ltd.20040—
+2K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+2K080386Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC20084—
+3K121483Reusable Cutaneous ElectrodeAmpcare, LLC20121—
+3K083756Guardian 150 ElectrodeSelectivemed Components, Inc.20093—
+4K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd.20180—
+4K113375Eswallow Usa Electrode,Eswallow Usa LeadwireEswallow USA20130—