Wearable Breast Pump (Model S32A)

K261199 · Shenzhen TPH Technology Co., Ltd. · HGX · Jul 13, 2026 · Obstetrics/Gynecology

Device Facts

• Record ID: K261199
• Device Name: Wearable Breast Pump (Model S32A)
• Applicant: Shenzhen TPH Technology Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Jul 13, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Wearable Breast Pump (Model S32A) 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 Story

Electrically powered wearable single breast pump; designed for hands-free use inside user's bra. Components include flange, pump motor, silicone diaphragm, milk collector, bra adjustment buckle, and valve. Operates by creating seal around nipple via flange; applies/releases suction to express milk into collection container. Backflow protection membrane prevents milk from entering vacuum system. User interface on motor unit allows selection of stimulation, expression, massage, and auto modes with adjustable vacuum levels. Powered by internal rechargeable lithium-ion polymer battery; charged via 5V DC adapter. Used by lactating women in home environment. Output is expressed breast milk for storage. Benefits include hands-free operation and portability for milk expression.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included vacuum level verification, backflow protection, use-life testing, battery performance, and battery status indicator functionality. Biocompatibility (cytotoxicity, sensitization, irritation) and electrical/EMC safety were demonstrated via testing leveraged from predicate and previous submissions.

Technological Characteristics

Materials: Polypropylene (milk collector), Silicone (flange/valve/diaphragm), ABS (motor housing). Energy: Internal Li-Ion polymer battery, 5V DC charging. Dimensions: Wearable form factor. Connectivity: None. Sterilization: Provided non-sterile. Software: Embedded, non-updatable by user. Standards: ANSI/AAMI ES60601-1, IEC 62133-2, IEC 60601-1-11, IEC 60601-1-2, ISO 10993-1.

Indications for Use

Indicated for lactating women to express and collect milk from their breasts. Intended for single-user, home-use.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Wearable Breast Pump (Model S32) (K240536)

Submission Summary (Full Text)

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July 13, 2026

Shenzhen TPH Technology Co., Ltd.

Dale WANG

Regulatory Affairs Engineer

Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology Park

#21 Bulan Rd., Xialilang Community, Nanwanstreet, Longgang

Shenzhen, Guangdong 518100

CHINA

Re: K261199

Trade/Device Name: Wearable Breast Pump (Model S32A)

Regulation Number: 21 CFR 884.5160

Regulation Name: Powered Breast Pump

Regulatory Class: II

Product Code: HGX

Dated: April 13, 2026

Received: April 13, 2026

Dear Dale WANG:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: The Center for Devices and Radiological Health (CDRH) does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D.

Assistant Director

DHT3B: Division of Reproductive,

Gynecology, and Urology Devices

OHT3: Office of Gastrorenal, ObGyn,

General Hospital, and Urology Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

510(k) Number (if known)

K261199

Device Name

Wearable Breast Pump (Model S32A)

Indications for Use (Describe)

The Wearable Breast Pump (Model S32A) 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.

Type of Use (Select one or both, as applicable)

☐

Prescription Use (Part 21 CFR 801 Subpart D)

☑

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/23)

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PSC Publishing Services [phone]

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# 510(k) Summary – K261199

## 1. Submitter Information

Applicant: Shenzhen TPH Technology Co., Ltd.
Address: Room 203, 2nd floor, 29th Building,
Lianchuang Technology Park, No.21 Bulan
Road, Xialilang Community, Nanwan
Street, Longgang District, Shenzhen, China
518000
Tel.: [phone]

## 2. Correspondent Information

Contact: Dale Wang
Title: Regulatory Affairs Engineer
Company: Shenzhen TPH Technology Co., Ltd.
Email: [e-mail]

## 3. Date prepared: July 13, 2026

## 4. Device Information

| Device Name: | Wearable Breast Pump (Model S32A) |
| --- | --- |
| Common Name: | Powered Breast Pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Powered Breast Pump |
| Product Code: | HGX (Pump, Breast, Powered) |
| Regulatory Class: | Class II |

## 5. Predicate Device Information

| Device Name: | Wearable Breast Pump (Model S32) |
| --- | --- |
| 510(k) Number: | K240536 |
| Manufacturer: | Shenzhen TPH Technology Co., Ltd. |

The predicate device has not been subject to a design-related recall.

## 6. Device Description

The Wearable Breast Pump (Model S32A), is an electrically powered wearable single breast pump consisting of the following key components: a flange, pump motor, silicone diaphragm, milk collector, bra adjustment buckle, and valve. It is designed to work in the user’s bra and has a rechargeable battery so it can be used hands-free 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, expression, massage, and auto modes and control the vacuum levels within those modes.

All available modes consist of 12 vacuum levels. The S32A model is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 86-110 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 33-109 cycles per minute in expression mode, vacuum levels from 40-120 mmHg with cycling rates from 90-120 cycles per minute in massage mode, and vacuum levels from 40-245 mmHg with cycling rates from 33-120 cycles per minute in auto mode. The model S32A Wearable Breast Pump is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery.

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The motor unit operates on embedded software. 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 motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk 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, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

### 7. Indications for Use

The Wearable Breast Pump (Model S32A) 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.

### 8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below compares the intended use and technological characteristics of the subject and predicate device.

Table 1: Comparator Table for Subject and Predicate Devices

| | Wearable Breast Pump (Model S32A) K261199 Subject Device | Wearable Breast Pump (Model S32) K240536 Predicate Device | Comparison |
| --- | --- | --- | --- |
| Indications for use | The Wearable Breast Pump (Model S32A) 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. | The Wearable Breast Pump (Model S32) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. | Similar |
| Code | HGX | HGX | Same |
| Single User | Yes | Yes | Same |
| Single/double pump | Single | Single | Same |
| Media separation (backflow protection) | Yes | Yes | Same |
| Cycling control mechanism | Microcontroller | Microcontroller | Same |
| Expression pattern | 2-Phase | 2-Phase | Same |
| Power supply | Li-Ion Battery | Li-Ion Battery | Same |
| Suction levels (stimulation) | 40 – 160 mmHg | 40 – 120 mmHg | Different |
| Suction levels (expression) | 120 – 245 mmHg | 120 – 245 mmHg | Same |
| Suction levels (massage) | 40 – 120 mmHg | 40 – 120 mmHg | Same |

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| Suction levels (auto) | 40 – 245 mmHg | 40 – 245 mmHg | Same |
| --- | --- | --- | --- |
| Cycles per minute (stimulation) | 86 – 110 | 86 – 110 | Same |
| Cycles per minute (expression) | 33 – 109 | 33 – 109 | Same |
| Cycles per minute (massage) | 90 – 120 | 90 – 120 | Same |
| Cycles per minute (auto) | 33 – 120 | 33 – 120 | Same |
| Available modes | 4 modes (stimulation, expression, massage, auto) | 4 modes (stimulation, expression, massage, auto) | Same |
| Suction levels | 12 levels each mode | 9 Levels each mode | Different |
| User Interface | On-Off switch, vacuum adjustment, mode change/power | On-Off switch, vacuum adjustment, mode change/power | Same |
| Adjustable Suction Levels | Yes | Yes | Same |
| Mobile Application | No | No | Same |
| Design | Wearable Milk Collector and Flange | Wearable Milk Collector and Flange | Same |
| Materials | Milk collector: Polypropylene Flange/valve/diaphragm: Silicone Pump Motor housing: ABS | Milk collector: Polypropylene Flange/valve/diaphragm: Silicone Pump Motor housing: ABS | Same |
| Flange/Insert size | 24 and 27 mm | 24 and 27 mm | Same |

The indications for use of the subject and predicate device are comparable, and they have the same intended use (i.e., for collection of breast milk from the breasts of lactating women).

The subject and predicate devices have similar technological features, including wearable operation, power supply, and user interface. However, as shown in the table above, there are technological differences between the subject and predicate device, including different overall vacuum/cycle specifications and available modes. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.

### 9. Summary of Non-Clinical Performance Testing

#### Biocompatibility

Biocompatibility information was leveraged from K250463 and was in accordance with the 2023 FDA guidance document Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process.” The following tests were conducted on the leveraged device:

- Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-10:2010)
- Skin Irritation (ISO 10993-10:2010)

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The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.

# **Electrical Safety**

Testing was leveraged from the predicate, K240536, and was in accordance with ANSI/AAMI ES60601-1:2005/A2:2010 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems, and IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

# **Electromagnetic Compatibility**

Testing was leveraged from the predicate, K240536, and was in accordance with IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: “General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.”

# **Software**

Software was evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document “Content of Premarket Submissions for Device Software Functions.”

# **Performance Testing**

Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:

- Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
- Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
- Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
- Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.

# **10. Conclusion**

The results of the performance testing described above demonstrate that the Wearable Breast Pump (Model S32A) is as safe and effective as the predicate device and supports a determination of substantial equivalence to the predicate device.