Pump In Style® Pro+

The Pump In Style Pro+ is a powered double electric breast pump designed for lactating women to express and collect breast milk from their breasts. It is intended for single-user home use and features 2-Phase Expression technology that mimics a baby's natural nursing rhythm by cycling through stimulation and expression phases.

The subject device differs from the predicate Pump In Style by offering 16 suction levels instead of 10, an internal rechargeable lithium-ion battery instead of external AA batteries, LED visual indicators for vacuum level/battery status/pumping phase, and hands-free collection cup options. Both devices use a microcontroller-driven membrane aggregate to generate negative pressure, support single and double pumping, and employ similar backflow protection mechanisms.

ANSI AAMI ES60601-1:2005/(R)2012 & amendments (electrical safety), IEC 60601-1-11:2015 (home healthcare environment), IEC 60601-1-2:2014/AMD1:2020 (electromagnetic compatibility), ISO 10993-1:2023 (biocompatibility), and 2023 FDA Guidance on Device Software Functions.

The devices share identical indications for use, intended environment, and basic function. Technological differences—number of suction levels, battery type, visual indicators, and detachable components—do not raise new safety or effectiveness questions and are supported by comprehensive performance testing including vacuum verification, battery function, and backflow protection studies that demonstrate the subject device is as safe and effective as the predicate.