510(k) K253946

Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) by Shenzhen Root Innovation Technology Co., Ltd. — Product Code HGX

K253946 is an FDA 510(k) premarket notification submitted by Shenzhen Root Innovation Technology Co., Ltd. for the device "Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)". The FDA issued a decision of Substantially Equivalent on April 7, 2026. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Shenzhen Root Innovation Technology Co., Ltd. has at least 10 other 510(k) clearances on record.