510(k) K221199

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) by Green Island International Tcm Group Limited — Product Code GXY

K221199 is an FDA 510(k) premarket notification submitted by Green Island International Tcm Group Limited for the device "Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)". The FDA issued a decision of Substantially Equivalent on December 19, 2023. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320.