eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;

The eufy Wearable Breast Pump models (S1, E10, S1 Pro, E20) are electrically powered, software-controlled breast pumps designed for lactating women to express and collect milk. The devices are wearable, hands-free units with rechargeable Li-ion batteries that operate in two modes (Stimulation and Expression) with adjustable suction levels ranging from 40-245 mmHg and cycle speeds of 20-92 cycles per minute.

The subject devices have identical technological features to the predicate (Model S18): same device design, control mechanism (microprocessor-based), power source (Li-ion battery), materials (polypropylene, silicone, ABS), backflow protection, suction modes and pressures, cycle speeds, and user interface. The key difference is that subject devices include multiple components per model (e.g., 2-4 milk collectors and flanges) compared to the predicate's single components, but these represent configuration variations rather than design changes.

Not stated in this summary. The document references compliance with 21 CFR 177 for milk-contacting materials and 21 CFR 820 quality system requirements, but does not cite specific ISO, IEC, or ASTM consensus standards.

Substantial equivalence is supported because the subject devices have identical indications for use, identical software, identical electrical design and components, and identical functional specifications (suction levels, cycle speeds, modes) as the predicate. Biocompatibility, electrical safety, EMC, and software verification & validation data were leveraged directly from the predicate. Performance testing (vacuum, cycle frequency, backflow, use life, battery) demonstrates the devices meet identical design requirements. The component quantity differences do not raise different safety or effectiveness questions since they represent the same design operating at the same specifications.