Wearable Breast Pump (Model W6)

The Wearable Breast Pump (Model W6) is a powered breast pump intended for use by lactating women to express and collect breast milk. It is battery-powered, wearable, designed for single-user operation in a home environment, and provided non-sterile.

The W6 offers 12 adjustable vacuum levels (40–245 mmHg) across four operating modes (stimulation, expression, massage, and auto), compared to the predicate S12's 9 levels in two modes. The W6 includes a hot compress function (≤42°C) not present in the S12. Both devices use lithium-ion batteries, microcontroller-based cycling, and backflow protection membranes to separate milk contact from vacuum systems.

Testing followed IEC 60601-1 Edition 3.2 (medical electrical equipment safety), IEC 62133-2:2017 (lithium battery safety), IEC 60601-1-11 Edition 3.1 (home healthcare requirements), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), ISO 10993-1 (biocompatibility), and FDA 2023 guidance on device software documentation.

Although the W6 differs from the predicate S12 in vacuum ranges, cycling rates, available modes, and inclusion of a warming feature, these differences do not raise different questions of safety or effectiveness because all components maintain the same fundamental function and design principle (wearable milk expression via microcontroller-managed suction), use equivalent materials and power systems, meet the same regulatory standards, and underwent comprehensive performance testing demonstrating they meet design specifications throughout intended use life.