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510(k) Data Aggregation
K Number
K151284Device Name
Electric Double Breast Pumps
Manufacturer
Date Cleared
2015-12-21
(221 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Wuxi Xinzhongrui Baby Supplies Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powered Electric Double Breast Pumps are intended to express and collect milk from the breast of a lactating woman. They are double pumps with a single pumping option and intended for single user.
Device Description
The Electric Double Breast Pumps are designed and manufactured to express and collect milk from a lactating woman's breast. Both models, XB-8636 and XB-8703, are electrically powered, softwarecontrolled, digital single-user pumps.
When powered, the XB-8636 starts with stimulation mode for 120 seconds then automatically switches to expression mode for 30 minutes before automatic shutdown. This model has seven suction levels. When powered, the XB-8703 starts with stimulation mode for 180 seconds then automatically switches to expression mode for 30 minutes before automatic shutdown. This model has nine suction levels. Both models allow the user to adjust the suction levels when necessary.
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