510(k) Report

Devices descending from K180865

9 later devices reach ZMI Self-Adhesive Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250841Electrotherapy ElectrodesBaisheng Medical Co., Ltd.20250—
+1K222252Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd.20236—
+1K222453Self-adhesive ElectrodeGuangdong Comytens Medical Technology Co., Ltd.20220—
+2K223802accufitMettler Electronics Corporation20235—
+3K233926accufitMettler Electronics Corporation20244—
+4K251594truFlexSyrma Johari Medtech Limited20250—
+4K241685SofWave SystemSofwave Medical, Ltd.20242—
+5K250146SofWave SystemSofwave Medical, Ltd.20251—
+6K251746Pure ImpactSofwave Medical, Ltd.20250—