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510(k) Data Aggregation
K Number
K252630Device Name
Electric Breast Pump (HL-3060, F5113)Date Cleared
2025-10-27
(68 days)
Product Code
Regulation Number
884.5160Type
TraditionalReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Electric Breast Pump (Models HL-3060, F5113) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.
Device Description
The Electric Breast Pump (Models HL-3060, F5113) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
AI/ML Overview
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