510(k) K241004

Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. — Product Code HGX

K241004 is an FDA 510(k) premarket notification submitted by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. for the device "Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)". The FDA issued a decision of Substantially Equivalent on September 11, 2024. 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.