510(k) Report

Devices descending from K070612

35 later devices reach Top-Rank Adhesive Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131720Hivox Self Adhesive Electrode Gel PadsHivox Biotek, Inc.20140—
+1K132588Adhesive ElectrodesTop-Rank Health Care Equipment Co., Ltd.20136—
+1K080276Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc.200831—
+2K170744Adhesive ElectrodesReno Medical, Ltd.20170—
+2K160081TENS ElectrodesCathay Manufacturing Corp.20163—
+2K090198Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd.200926—
+3K213879Self-adhesive ElectrodeBozhou Rongjian Medical Appliance Co., Ltd.20221—
+3K210448Adhesive ElectrodeShaoxing Yingtuo Healthcare Co., Ltd.20210—
+3K192568Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd.20210—
+3K180773Reusable and Self-Adhesive ElectrodesShaoxing Dongzhi Electrical Technology Co., Ltd.20180—
+3K171722Electrodes with snap / Electrodes with pigtailShenzhen Konmed Technology Co., Ltd.20180—
+3K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd20164—
+3K150971Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd.20155—
+3K132998Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd.201316—
+4K252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.20260—
+4K190700Electrodes PadShenzhen Bestpad Technology Development Co., Ltd.20191—
+4K183154SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited20190—
+4K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd.20193—
+4K180865ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd.20189—
+4K171381Adhesive ElectrodesShenzhen Quality Medical Technology Co.,Ltd20172—
+4K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd.201615—
+5K250841Electrotherapy ElectrodesBaisheng Medical Co., Ltd.20250—
+5K241512Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd20251—
+5K221589Starly padShenzhen Xingyuanli Technology Co., Ltd.20230—
+5K222252Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd.20236—
+5K223775EZ-STIK ElectrodesSouth Dakota Partners20230—
+5K222453Self-adhesive ElectrodeGuangdong Comytens Medical Technology Co., Ltd.20220—
+5K212191Adhesive ElectrodesVoncare Medical Device Co., Ltd.20210—
+6K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi20260—
+6K223802accufitMettler Electronics Corporation20235—
+7K233926accufitMettler Electronics Corporation20244—
+8K251594truFlexSyrma Johari Medtech Limited20250—
+8K241685SofWave SystemSofwave Medical, Ltd.20242—
+9K250146SofWave SystemSofwave Medical, Ltd.20251—
+10K251746Pure ImpactSofwave Medical, Ltd.20250—