510(k) Report

Devices descending from K945676

45 later devices reach Guardian Disposable Tens and Tens/Nmes Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083756Guardian 150 ElectrodeSelectivemed Components, Inc.20093—
+1K050469EZ-Stik ElectrodesNaimco, Inc.2005404
+2K223775EZ-STIK ElectrodesSouth Dakota Partners20230—
+2K113375Eswallow Usa Electrode,Eswallow Usa LeadwireEswallow USA20130—
+2K121483Reusable Cutaneous ElectrodeAmpcare, LLC20121—
+2K092546Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM…Gmdasz Manufacturing Co., Ltd.200916—
+2K052875Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC200522—
+3K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd.20180—
+3K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd.201615—
+3K062675Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double…Gemore Technology Co, Ltd.200721—
+4K222252Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd.20236—
+4K212191Adhesive ElectrodesVoncare Medical Device Co., Ltd.20210—
+4K180865ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd.20189—
+4K171381Adhesive ElectrodesShenzhen Quality Medical Technology Co.,Ltd20172—
+4K083302Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd200914—
+4K082065Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited20095—
+5K250841Electrotherapy ElectrodesBaisheng Medical Co., Ltd.20250—
+5K223802accufitMettler Electronics Corporation20235—
+5K222453Self-adhesive ElectrodeGuangdong Comytens Medical Technology Co., Ltd.20220—
+5K190700Electrodes PadShenzhen Bestpad Technology Development Co., Ltd.20191—
+5K132422Pals Platinum Neurostimulation ElectrodesAxelgaard Mfg. Co., Ltd.20140—
+5K133723Otc PatchWell-Life Healthcare Limited20143—
+5K130987Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd.201310—
+5K120516Long Life PadtmOmron Healthcare, Inc.20120—
+5K112312TheratrodePhoenix Medical Devices, Llp20122—
+6K233926accufitMettler Electronics Corporation20244—
+6K221589Starly padShenzhen Xingyuanli Technology Co., Ltd.20230—
+6K220524Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited20220—
+6K152815Mailuokang Self-adhesive ElectrodeShenzhen Mailuokang Technology Co., Ltd.20161—
+6K151479EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd20150—
+6K150971Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd.20155—
+6K151033Philips Self-Adhesive ElectrodesPhilips Consumer Lifestyle20150—
+6K150681Gemore Otc TensGemore Technology Co, Ltd.20150—
+6K140586Ascend ElectrodeNeurometrix, Inc.20141—
+7K251594truFlexSyrma Johari Medtech Limited20250—
+7K241685SofWave SystemSofwave Medical, Ltd.20242—
+7K230533Motive™ ElectrodeCymedica Orthopedics, Inc.20230—
+7K181234Self-adhesive ElectrodeDong Guan OU Kang Electronics Co., Ltd.20180—
+7K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd20164—
+8K250146SofWave SystemSofwave Medical, Ltd.20251—
+8K183154SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited20190—
+8K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd.20193—
+9K251746Pure ImpactSofwave Medical, Ltd.20250—
+9K241512Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd20251—
+10K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi20260—