510(k) Report

Devices descending from K092546

16 later devices reach Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd.201615—
+2K222252Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd.20236—
+2K223775EZ-STIK ElectrodesSouth Dakota Partners20230—
+2K212191Adhesive ElectrodesVoncare Medical Device Co., Ltd.20210—
+2K180865ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd.20189—
+2K171381Adhesive ElectrodesShenzhen Quality Medical Technology Co.,Ltd20172—
+3K250841Electrotherapy ElectrodesBaisheng Medical Co., Ltd.20250—
+3K223802accufitMettler Electronics Corporation20235—
+3K222453Self-adhesive ElectrodeGuangdong Comytens Medical Technology Co., Ltd.20220—
+3K190700Electrodes PadShenzhen Bestpad Technology Development Co., Ltd.20191—
+4K233926accufitMettler Electronics Corporation20244—
+4K221589Starly padShenzhen Xingyuanli Technology Co., Ltd.20230—
+5K251594truFlexSyrma Johari Medtech Limited20250—
+5K241685SofWave SystemSofwave Medical, Ltd.20242—
+6K250146SofWave SystemSofwave Medical, Ltd.20251—
+7K251746Pure ImpactSofwave Medical, Ltd.20250—