510(k) K250070

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) by Shenzhen Changkun Technology Co., Ltd. — Product Code HGX

K250070 is an FDA 510(k) premarket notification submitted by Shenzhen Changkun Technology Co., Ltd. for the device "Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)". The FDA issued a decision of Substantially Equivalent on June 26, 2026. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Shenzhen Changkun Technology Co., Ltd. has at least 6 other 510(k) clearances on record.