Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)

The Momcozy Wearable Breast Pump is a powered breast pump designed for lactating women to express and collect milk from their breasts for a single user. The device is battery-powered, wearable, and features adjustable vacuum levels and multiple pumping modes (stimulation, expression, and mixed).

Key differences from the predicate include: the subject device uses a rechargeable lithium-ion polymer battery (3.7V) whereas the predicate used AC mains power or AA batteries; the subject offers vacuum ranges of 80–290 mmHg with 15 or 9 adjustable levels depending on model, compared to the predicate's 40–290 mmHg with 9 levels; and cycling rates differ between the two. Both use microcontroller-based systems, 2-phase expression patterns, and media separation (backflow protection).

Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-23 (skin sensitization), and ISO 10993-10 (skin irritation); electrical safety per ANSI/AAMI ES60601-1:2005/A2:2010 and IEC 62133-2:2017; electromagnetic compatibility per IEC 60601-1-2:2014; and software evaluation at Basic Documentation level per 2023 FDA guidance.

The subject and predicate devices share the same intended use (breast milk collection from lactating women), same product code (HGX), and similar core technological features including wearable design, microcontroller cycling control, 2-phase expression, adjustable suction levels, and backflow protection. Although the devices differ in power supply, specific vacuum ranges, and cycle rates, these differences do not raise new safety or effectiveness questions. Performance testing confirmed the subject device meets its design specifications across vacuum levels, backflow protection, use life, and battery function, demonstrating substantial equivalence to the predicate.