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510(k) Data Aggregation
K Number
K202802Device Name
TT Electric Breast Pump, TT Double Electric Breast Pump
Manufacturer
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
Date Cleared
2021-08-26
(337 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. This powered breast pump is intended for a single user and is intended to be used in a home environment.
Device Description
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. The devices are intended for a single user. The subject devices are for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile. The subject devices are electrically powered double (TT Double Electric Breast Pump) and single (TT Electric Breast Pump) breast pumps consisting of the following key components: a motor unit with a press-button user interface, pump body, LCD display, air tube connectors, and breast milk collection bottles. The motor unit operates on embedded software. Software updates by end-users are not supported. The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a protection membrane physically separates the milkcontacting pathway from the vacuum system. The motor unit operates on a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation. All other components of the subject devices are not in contact with the breast.
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K Number
K142479Device Name
MEGNA BREAST PUMPS
Manufacturer
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.
Date Cleared
2015-02-24
(173 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The powered Megna Breast Pumps are intended to express and collect milk from the breast of a lactating woman. The M5 model is a single pump. The M7, M10, and M12 models are double pumps with a single pumping option. All models are intended for single users.
Device Description
The Megna breast pumps are electrically powered breast pumps for over-the-counter use, intended to be used at home to express a nursing mother's breast milk. The Megna breast pumps are provided in 4 models: Model M5 - Megna Digital Single Breast Pump, Model M7 Megna Digital Double Breast Pump, Model M10 - Megna Digital Double Breast Pump, Model M12 - Megna Digital Double Breast Pump.
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