Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

The Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) are wearable-style powered breast pumps intended for use by lactating women to express and collect milk from their breasts. They are electrically powered, software-controlled devices designed for single-user operation in a home environment.

The subject devices offer three pumping modes (massage, expression, and mixed) with 10 adjustable vacuum levels per mode, vacuum ranges of 40–190 mmHg (massage) and 80–280 mmHg (expression/mixed), and cycling rates from 6–110 cycles per minute depending on mode. They differ from the predicate (Elvie Stride) in offering single-pump configuration only (versus single or double), providing a mixed mode not present in the predicate, and featuring different vacuum and cycle speed specifications. Control interfaces vary across models—some use physical buttons while others use touch keys—and display indicators include LED lights or LED screens depending on the model.

ANSI/AAMI ES60601-1:2005/A2:2010 (electrical safety), IEC 62133-2:2017/A1:2021 (lithium battery safety), IEC 60601-1-11:2015/A1:2020 (medical equipment in home healthcare), IEC 60601-1-2:2014/A1:2020 (electromagnetic compatibility), and ISO 10993-1 (biocompatibility). Software was evaluated at the Basic Documentation level per FDA guidance.

The subject and predicate devices share the same intended use (milk expression/collection from lactating women), regulatory classification (Class II), product code (HGX), and fundamental technological approach (wearable, microcontroller-based, powered, rechargeable battery, backflow protection, 10 adjustable suction levels). Although the subject devices differ in vacuum ranges, cycle speeds, available modes, and user interface controls, these differences do not raise different questions of safety and effectiveness because all specifications remain within clinically reasonable ranges for breast pump operation and the devices meet equivalent performance standards for biocompatibility, electrical safety, and electromagnetic compatibility.