510(k) Report

Devices descending from K160138

15 later devices reach Adhesive Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222252Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd.20236—
+1K223775EZ-STIK ElectrodesSouth Dakota Partners20230—
+1K212191Adhesive ElectrodesVoncare Medical Device Co., Ltd.20210—
+1K180865ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd.20189—
+1K171381Adhesive ElectrodesShenzhen Quality Medical Technology Co.,Ltd20172—
+2K250841Electrotherapy ElectrodesBaisheng Medical Co., Ltd.20250—
+2K223802accufitMettler Electronics Corporation20235—
+2K222453Self-adhesive ElectrodeGuangdong Comytens Medical Technology Co., Ltd.20220—
+2K190700Electrodes PadShenzhen Bestpad Technology Development Co., Ltd.20191—
+3K233926accufitMettler Electronics Corporation20244—
+3K221589Starly padShenzhen Xingyuanli Technology Co., Ltd.20230—
+4K251594truFlexSyrma Johari Medtech Limited20250—
+4K241685SofWave SystemSofwave Medical, Ltd.20242—
+5K250146SofWave SystemSofwave Medical, Ltd.20251—
+6K251746Pure ImpactSofwave Medical, Ltd.20250—