K-number	K252192
Device name	Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
Applicant	Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Product code	HGX
Device class	Class II
Decision date	Aug 13, 2025
Decision	Substantially Equivalent
Regulation	884.5160

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Wearable Breast Pump (models P9, P10, P16, P20, P21, P22, P23, P25) is a powered breast pump designed for lactating women to express and collect milk from their breasts. It is intended for single-user application and is classified as an over-the-counter device.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document confirms the device is substantially equivalent to legally marketed predicate devices or reclassified devices, but the specific predicate device(s) and the detailed technical or functional comparisons supporting this determination are contained in the referenced enclosure, which is not provided in this document.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)

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