K-number	K241680
Device name	Momcozy Wearable Breast Pump (BP311)
Applicant	Shenzhen Root Innovation Technology Co., Ltd.
Product code	HGX
Device class	Class II
Decision date	Dec 20, 2024
Decision	Substantially Equivalent
Regulation	884.5160

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Momcozy Wearable Breast Pump (BP311) is a powered breast pump designed to express milk from lactating women's breasts for collection. It is intended for single-user application and is classified as a Class II medical device under 21 CFR 884.5160.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Momcozy Wearable Breast Pump (BP311)

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