Wearable Electric Breast Pump (YM-8803)

The Wearable Electric Breast Pump (YM-8803) is a powered breast pump designed to express milk from lactating women's breasts for collection. It is intended for single-user, over-the-counter home use. The device creates suction around the nipple and applies and releases pressure to stimulate lactation and extract milk into a collection container.

The subject device features double pumping options (versus single for the predicate), a microprocessor-controlled diaphragm-type vacuum pump with two modes—Stimulation (-70 to -150 mmHg, 68–115 cycles/min) and Expression (-80 to -280 mmHg, 34–101 cycles/min)—each with 9 adjustable suction levels. It uses a rechargeable 3.7V lithium-ion battery with backflow protection and a 24mm flange (with optional 21mm and 27mm shields). These differ from the predicate's single-pumping option and suction ranges, but operate on similar microcontroller principles.

IEC 60601-1:2005 and amendments (electrical safety); IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility); IEC 60601-1-11:2015+A1:2020 (home healthcare environment); IEC 60601-1-6:2010+A2:2020 (usability); IEC 62133-2:2017+A1:2021 (lithium battery safety); ISO 10993-5, 10993-23, and 10993-10 (biocompatibility: cytotoxicity, skin irritation, skin sensitization); vacuum, backflow, cycle speed, and battery capacity testing per design specifications.

The subject device has identical indications for use to the predicate (milk expression and collection from lactating women for single-user home use) and the same intended patient population and environment. Although technological differences exist in pumping options, suction strength, and cycle speed, these differences do not raise new safety or effectiveness questions. Non-clinical testing demonstrates compliance with relevant electrical safety, biocompatibility, and performance standards comparable to the predicate device.