Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)

The Momcozy Wearable Breast Pump (Models BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) is a powered breast pump intended to express milk from lactating women's breasts for collection and storage. The device is battery-powered, wearable, operates via LED controls and mobile app, and is intended for single-user home use.

The subject device uses a diaphragm-type vacuum pump driven by microcontroller, provides 15 vacuum levels across multiple modes (stimulation, expression, mixed, auto, and personalized), operates at 75–285 mmHg with cycling rates of 25–90 cycles per minute depending on mode, and includes a rechargeable lithium-ion battery with companion charging case. Key differences from the predicate include additional personalized modes, slightly different vacuum/cycle specifications, removal of Tritan from materials, and simplified controls without left/right toggle buttons.

ANSI/AAMI ES60601-1:2005/A2:2010 (electrical safety), IEC 62133-2:2017 (lithium battery safety), IEC 60601-1-11:2015 (home healthcare environment), IEC 60601-1-2:2014 (electromagnetic compatibility), ISO 10993-1:2023 (biocompatibility), and FDA guidance documents on device software and cybersecurity.

The subject and predicate devices have identical indications for use, same product code (HGX), and similar core technological features including wearable operation, diaphragm pump type, microcontroller cycling control, and mobile app integration. Although there are differences in vacuum ranges, cycle speeds, control interface, and materials, these differences do not raise different questions of safety and effectiveness, and performance testing demonstrates the subject device meets design requirements and is as safe and effective as the predicate.