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 Momcozy Wearable Breast Pump is a powered breast pump intended for lactating women to express and collect milk from their breasts for a single user. The device is battery-powered and controlled by embedded software, featuring buttons, LED display, and multiple operating modes (stimulation, expression, and mixed for S12 Pro series) with adjustable vacuum levels.

The subject device differs from the predicate in power supply (rechargeable lithium battery vs. mains adapter or AA batteries), vacuum/cycle specifications across modes, and available modes (adds mixed mode to S12 Pro series). Both use microcontroller-based cycling, 2-phase expression patterns, backflow protection, and similar user interfaces. The subject devices are wearable; the predicate includes both wearable and tabletop models.

Biocompatibility per ISO 10993-1 (2023 FDA guidance); electrical safety per ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015; electromagnetic compatibility per FDA EMC guidance and IEC 60601-1-2:2014; software evaluated at Basic Documentation level per 2023 FDA guidance.

The subject and predicate devices have identical indications for use and similar core technological features including microcontroller cycling, 2-phase expression, and backflow protection. Differences in vacuum levels, cycles per minute, power supply, and available modes do not raise different questions of safety and effectiveness. Performance testing confirms the subject devices meet design requirements and maintain specifications throughout use life, supporting substantial equivalence.