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510(k) Data Aggregation
K Number
K240218Device Name
Electric Breast Pump (F5055)
Date Cleared
2024-10-17
(265 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
**Fimilla (Shanghai) maternity **& baby Articles Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Electric Breast Pump (F5055) 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 (F5055) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump (F5055) is intended for a single user. The proposed device is electrically powered and software-controlled. The device operates via a microprocessor-driven air pump, which generates suction on the breast to extract milk. The proposed device is available in one model, F5055. The provided non-sterile and is not to be sterilized by the user prior to use. The device includes a breast shield assembly, bottles, pump unit, tubing, an adapter, and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body that contacts the user's breast.
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