510(k) Report

Devices descending from K020735

32 later devices reach Sof-Pach Reusable Neurostimulation Electrodes through their predicates, nearest generation first.

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