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510(k) Data Aggregation
K Number
K150923Device Name
Breast Pump
Manufacturer
Date Cleared
2015-11-06
(214 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Jinxinbao Electronic Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BR128 Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.
Device Description
The BR128 is an electrically powered breast pump that uses negative pressure to express milk from the breasts of lactating women. It adopts a Single-Chip Microcomputer to imitate a baby's suckling action and a reciprocating vacuum pump to generate the suction to extract the milk at vacuum levels between 0 and 170mmHg. It is intended for single pumping.
It is designed to mechanically interface with a mother's breast via a massage cushion and withdraw then collect the breast milk. The motor unit of the device is connected to the bottle via a silicone tube. Its suction strength is adjustable via the suction adjustment button on the device, but its cycles per minute are controlled by software and cannot be adjusted. The device can be powered by batteries or the provided mains adapter.
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