eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

The eufy Wearable Breast Pump S1 and E10 are electrically powered, wearable single breast pumps intended for lactating women to express and collect milk from their breasts for a single user. The S1 includes heating and magnetic charging; the E10 uses Type-C charging without heating. Both are closed-system pumps with anti-backflow diaphragms powered by rechargeable lithium-ion batteries and controllable via physical buttons or an optional smartphone app.

The subject devices differ from the predicate (Perifit Pump) in several non-critical ways: 7 suction levels versus 8; vacuum range of -75 to -292.5 mmHg versus -30 to -300 mmHg; cycle speeds of 71–110 cycles/minute (stimulation) and 39–60 cycles/minute (expression) versus 68–120 and 28–80; flange sizes of 15, 17, 19, 21, 24, 27 mm versus 18, 21, 24, 27 mm; materials including polypropylene, silicone, and acrylonitrile butadiene versus PC/ABS plastic. Both share identical intended use, patient population, backflow protection, two suction modes, microcontroller cycling, Li-ion battery power, and optional app control.

ANSI AAMI ES60601-1:2005/(R)2012 (medical electrical equipment safety); ANSI AAMI IEC 60601-1-2:2014 (electromagnetic compatibility); ANSI AAMI HA60601-1-11:2015 (home healthcare environment); IEC 62133-2 Edition 1.0 2017-02 (lithium battery safety); ISTA 3A:2018 (packaging simulation); ANSI AAMI ISO 10993-5:2009/(R)2014 (cytotoxicity); ISO 10993-10 Fourth edition 2021-11 (skin sensitization); ISO 10993-23 First edition 2021-01 (irritation).

Both devices share identical intended use (expressing and collecting breast milk), patient population (lactating women), fundamental operating principles (microcontroller-regulated two-mode suction with adjustable vacuum levels), and safety features (backflow protection, Li-ion battery power, optional app control). Although the subject devices have different technical specifications (suction levels, vacuum ranges, cycle speeds, flange sizes, and materials), these differences do not raise different questions of safety or effectiveness because all performance parameters remain within clinically appropriate ranges for breast milk expression. Comprehensive testing (electrical safety, electromagnetic compatibility, biocompatibility, packaging integrity, and software validation) demonstrates the subject devices perform as safely and effectively as the predicate.