510(k) K190118

Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) by Guangzhou Xinbo Electronic Co., Ltd. — Product Code GXY

K190118 is an FDA 510(k) premarket notification submitted by Guangzhou Xinbo Electronic Co., Ltd. for the device "Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)". The FDA issued a decision of Substantially Equivalent on May 13, 2020. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Guangzhou Xinbo Electronic Co., Ltd. has at least 10 other 510(k) clearances on record.