Momcozy Wearable Breast Pump (BP223)

The Momcozy Wearable Breast Pump (BP223) is a battery-powered breast pump designed for lactating women to express and collect milk from their breasts for a single user. It features stimulation, expression, and mixed modes with microprocessor-controlled suction and cycle speed, a diaphragm-type vacuum pump, backflow protection, and optional mobile app connectivity for personalized pumping sessions and output tracking.

The subject device differs from the predicate in several ways: it offers 15 suction levels versus the predicate's 9 expression levels, operates on a 3.7V Li-ion rechargeable battery versus the predicate's mains power or AA batteries, achieves different vacuum ranges (stimulation −65 to −174 mmHg; expression −109 to −305 mmHg) versus the predicate's ±30 mmHg tolerance, uses different cycle speeds, includes mobile app connectivity absent in the predicate, and is wearable whereas most predicate models are tabletop.

ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (skin irritation), IEC 60601-1-2 (electromagnetic compatibility), ANSI AAMI ES60601-1 (electrical safety), IEC 60601-1-11 (home healthcare environment), IEC 62133-2 (lithium battery safety). Software evaluated per 2023 FDA guidance on Basic Documentation level; cybersecurity per 2023 FDA guidance. Additional non-clinical testing included suction and cycle speed, backflow protection, battery capacity, and one-year use life testing.

Although the subject device differs technologically (battery power, wearable design, mobile app, different suction/cycle specifications), these differences do not raise new safety or effectiveness questions because both devices use the same fundamental mechanism (microcontroller-driven diaphragm vacuum pump with backflow protection) for the identical intended use (milk expression from lactating women). Biocompatibility, electrical safety, and performance testing demonstrate the subject device is as safe and effective as the predicate, and the technological variations represent only design optimization rather than a change in the basic operating principle or risk profile.