Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)

The Electric Breast Pump (models LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is an electrically powered device used by lactating women to express and collect breast milk. It can operate in single or double pumping mode and features multiple operational modes including stimulation, expression, bionic sucking, and variable frequency modes, with adjustable suction levels and cycle speeds.

The subject device differs from the predicate (YM-8166) in power supply options (USB charging and alkaline batteries versus DC 5V), vacuum pressure ranges (50-290 mmHg expression vs. 85-280 mmHg), cycle speeds (20-65 cpm expression vs. 24-84 cpm), available modes (4 modes vs. 5 modes), and overall suction level specifications. Both devices use microcontroller-based cycling, 2-phase expression patterns, and backflow protection via silicone diaphragm mechanisms.

IEC 60601-1 Edition 3.2 (medical electrical equipment safety), IEC 62133-2:2017 (lithium battery safety), IEC 60086-5:2016 (primary battery safety), IEC 60601-1-11 Edition 3.1 (home healthcare electrical equipment), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), and ISO 10993 standards (ISO 10993-5:2009 cytotoxicity, ISO 10993-10:2021 skin sensitization, ISO 10993-23:2021 skin irritation).

Although the subject device has different vacuum pressures, cycle speeds, operating modes, and power supply configurations than the predicate, these technological differences do not raise different questions of safety and effectiveness because both devices share the same intended use (expressing and collecting breast milk from lactating women), same regulatory classification (Class II), same product code (HGX), and fundamentally similar design architecture including microcontroller cycling control, 2-phase expression patterns, and backflow protection. Performance testing demonstrated the subject device meets its design specifications and maintains safety across all modes.