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510(k) Data Aggregation

    K Number
    K251754
    Device Name
    Wearable Breast Pump (Model S33)
    Manufacturer
    Shenzhen TPH Technology Co., Ltd.
    Date Cleared
    2025-09-08

    (91 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K242850
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wearable Breast Pump (Model S33) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

    Device Description

    The Wearable Breast Pump (Model S33) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast.

    It is an electrically powered, software-controlled, digital pump. It is powered by a rechargeable lithium ion battery (3.7 V, 1000mAh) that can be charged using the USB cable provided with the device. The device is designed not to be used during charging. The device utilizes an embedded control program to manage all product functions and does not incorporate any off-the-shelf (OTS) software. The main components of this pump include pump motor, valve, flange, silicone diaphragm, USB charging cable, bra extension strap and milk collector. The pump is provided non-sterile and reusable by a single user in home environment.

    There are four (4) operating modes available for the device – Stimulation mode, Expression mode, Massage mode, and Auto mode. The device includes nine (9) suction levels within each mode. Wearable Breast Pump (Model S33) is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 91 -121 cycles per minute in Stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 27-88 cycles per minute in Expression mode, vacuum levels from 40-120 mmHg with cycling rates from 92-130 cycles per minute in Massage mode and vacuum levels from 40-245 mmHg with cycling rates from 27-121 cycles per minute in auto mode. The device is equipped with an LED status display that displays information regarding working mode, operating time, and battery status. The user interface includes on/off switch that also acts as mode selection switch (through long press), pause button and vacuum level adjustment buttons.

    Wearable breast pump (Model S33) is designed to be used as a single pumping system that can be converted to double pumping by using two devices, one on each breast. To prevent milk from flowing into the vacuum system, the device uses a silicone diaphragm that physically separates the milk contacting pathway from the vacuum system. All milk contacting components of the device are compliant with 21 CFR 177.

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