510(k) K252192

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. — Product Code HGX

K252192 is an FDA 510(k) premarket notification submitted by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. for the device "Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)". The FDA issued a decision of Substantially Equivalent on August 13, 2025. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Huizhou Lvb Maternal and Infant Supplies Co., Ltd. has at least 2 other 510(k) clearances on record.