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510(k) Data Aggregation
K Number
K230776Device Name
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
Manufacturer
Shenzhen Lutejiacheng Technology Co., Ltd.
Date Cleared
2023-06-09
(80 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Lutejiacheng Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Device Description
Not Found
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K Number
K223693Device Name
Electric breast pump (model: M5)
Manufacturer
Shenzhen Lutejiacheng Technology Co., Ltd.
Date Cleared
2023-03-09
(90 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Lutejiacheng Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric breast pump (model: M5) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Device Description
Electric breast pump (model: M5)
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K Number
K220309Device Name
Wearable Breast Pump (Model S10)
Manufacturer
Shenzhen Lutejiacheng Technology Co., Ltd.
Date Cleared
2022-06-27
(145 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Lutejiacheng Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wearable Breast Pump (Model S10) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Device Description
The Wearable Breast Pump (Model S10), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, type-C USB cable, valve, and milk collector. It is designed to work in the user's bra and has a rechargeable battery so it can be used handsfree without any external power cords. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping). The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Both stimulation and expression mode consist of 9 vacuum levels. The S10 model is capable of providing vacuum levels from 45-112 mmHg with cycling rates from 49-100 cycles per minute in stimulation mode and vacuum levels from 133-225 mmHg with cycling rates from 20-57 cycles per minute in expression mode. The Wearable Breast Pump (Model S10) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.
The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter.
The subject device components are made of the following materials:
- Motor unit: acrylonitrile-butadiene-styrene (ABS) plastic
- · Flange, tube, valve, diaphragm: Silicone
- · Linker, milk collection container: Polypropylene
All milk contacting components are compliant with 21 CFR 174-179.
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