Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)

The Moon Wave (PA220) and Mini Moon (PA221) are electrically powered breast pumps for personal home use by lactating women. Both devices express and collect milk using dual-phase pumping (Stimulation and Expression modes) with adjustable suction levels and cycle speeds. They are not intended for hospital use.

Both subject devices use diaphragm-type pumps with microcontroller-based suction and cycle control, adjustable suction ranges (45–251 mmHg), and integrated silicone diaphragm backflow protection. The PA220 is a countertop device powered by 12V DC adapter or 7.4V lithium-ion battery; the PA221 is a compact wearable powered by 5V USB-C adapter or 3.7V lithium-ion battery. Both differ from the predicate mainly in form factor, user interface, power supply configuration, and specific suction/speed ranges—but maintain the same fundamental operating principles.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (electrical safety); IEC 60601-1-11:2015+A1:2020 (home healthcare); IEC 60601-1-2:2014+A1:2020 and CISPR 11 (EMC); IEC 62133-2:2017 (battery safety); ISO 10993-1:2018 (biocompatibility); ISO 14971:2019 (risk management); IEC 62304:2006+A1:2015 (software lifecycle).

The subject devices are substantially equivalent to the predicate (Rumble Tuff Electric Breast Pump, K113315) because they share the same intended use, regulatory class (Class II), product code (HGX), and fundamental operating principles including dual-phase pumping, adjustable suction, diaphragm-based backflow protection, and single-user home use. Design and user interface differences (form factor, power supply, interface layout) do not raise different questions of safety or effectiveness, and comprehensive nonclinical testing demonstrated compliance with applicable safety and performance standards.