Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
Device Facts
| Record ID | K252744 |
|---|---|
| Device Name | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) |
| Applicant | Cixi Ruihong Electric Appliance Co., Ltd. |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Apr 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Wearable Electric Breast Pump 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
Wearable electric breast pump; single-user; powered by rechargeable Li-ion battery. System comprises motor pump, breast shield, silicone diaphragm, valve, and storage tank. Microprocessor-controlled diaphragm-type vacuum pump regulates vacuum pressure and cycle speed. User interface on pump body includes LED status display for mode, vacuum level, and battery; buttons for power, mode selection, and suction adjustment. Three operating modes (stimulate, mixed, expression) with varying suction levels and cycle speeds. Device worn by user to express milk; output collected in storage tank. Benefits include portable, hands-free milk expression for lactating women.
Clinical Evidence
No clinical data. Bench testing only. Performance verification included vacuum pressure, cycle speed, backflow protection, battery capacity, and use-life (2 years). Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation) confirmed non-cytotoxic, non-irritating, and non-sensitizing materials. Electrical safety and EMC testing performed per IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133-2.
Technological Characteristics
Powered breast pump; microprocessor-controlled vacuum pump. Materials: silicone diaphragm. Power: 3.7V 1200mAh Li-ion battery. Connectivity: USB cable (charging). Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62133-2, ISO 10993-1/5/10/23. Software: Basic Documentation Level. Non-sterile, reusable.
Indications for Use
Indicated for lactating women requiring expression and collection of breast milk. Intended for single-user use.
Regulatory Classification
Identification
A powered breast pump in an electrically powered suction device used to express milk from the breast.
Predicate Devices
- Electric breast pump (Models: RH-228 and RH-338) (K201903)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 3, 2026
Cixi Ruihong Electric Appliance Co., Ltd.
% Garen Liu
Consulting consultant
Grzan medical technology (Shenzhen) Co., LTD.
Room 103-108, 1st Floor, Block B, Building 2
Bangkai Science and Tech Park, Guanguang Rd, Guangming Dist
Shenzhen, 518107
China
Re: K252744
Trade/Device Name: Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
Regulation Number: 21 CFR§ 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: March 3, 2026
Received: March 3, 2026
Dear Garen Liu:
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: 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, 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.
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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Reginald K. Avery -S
for
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: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252744 | |
| Device Name Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | |
| Indications for Use (Describe) The Wearable Electric Breast Pump 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
FORM FDA 3881 (6/20)
PEC Publishing Services (301) 443-6740
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K252744
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# 510k Summary – K252744
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
## 1. Information of Submitter and correspondent
### Submitter’s information
Submitter Name: Cixi Ruihong Electric Appliance Co., Ltd.
Submitter Address: No.18, Xiamaojia Road, Shuangqingpu Village, Xinpu Town, Cixi, Ningbo, 315322, Zhejiang, China.
Contact Person (including Title): Liu Feng (Quality Manager)
Tel: +86 13759593691
E-mail: 13759593691@139.com
Date of Preparation: April 3, 2026
### Contact information
Contact Address: Grzan Medical Technology (Shenzhen) Co., Ltd.
Rm. 103 – 108, 1st floor, Block B, Bldg. 2,
Bangkai Science And Tech Park, Guanguang Rd. Guangming Dist, Shenzhen, 518107, China.
Contact Person: Garen Liu
Tel: +86 13100734866
E-mail: garen@grzan.cn
## 2. Device Identification
Trade Name: Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
Common Name: Powered breast pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered breast pump
Product Code: HGX (Pump, Breast, Powered)
Classification Panel: Obstetrics/Gynecology
Regulatory Class: Class II
## 3. Predicate Device Information
| | Predicate Device |
| --- | --- |
| Sponsor | Cixi Ruihong Electric Appliance Co., Ltd. |
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| Device Name | Electric breast pump (Models: RH-228 and RH-338) |
| --- | --- |
| 510(k) Number | K201903 |
The predicate device has not been subject to a design-related recall.
## 4. Device Description
The Wearable Electric Breast Pump is an electrically powered wearable single breast pump. A diaphragm-type vacuum pump driven by a microprocessor, the microprocessor provides control over vacuum pressure and cycle speed. The Wearable Electric Breast pump consists of motor pump, breast shield, silicone diaphragm, USB cable, valve, storage tank and breast pump bracket.
There are four models (Models RH 668, RH 708, RH 718, RH 728) with 3 modes (stimulate mode, mixed mode and expression mode)
- Model RH 668 has 9 working levels
- Model RH 708 has 5 working levels
- Model RH 718 has 5 working levels
- Model RH 728 has 5 working levels
The subject device operates as a single or double pumping system, one on each breast. The pump is provided non-sterile and reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200 mmAh). The subject device is designed not to be used during charging.
There is a LED status display for the subject device, including working mode, vacuum level, and battery indicator, can be shown on the pump body. The user interface includes on/off switch, mode selection, and vacuum adjustment.
## 5. Indications for Use
The Wearable Electric Breast Pump 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.
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6. Comparison of Intended Use and Technological Characteristics with the Predicate Device
| Item | Subject device
K252744 | | Predicate device
K201903 | | Comment |
| --- | --- | --- | --- | --- | --- |
| Indications for Use | The Wearable Electric Breast Pump 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 Electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user. | | Similar |
| Pump Type | Wearable | | Hand-held | | Different |
| Media separation (backflow protection) | Yes | | Yes | | Same |
| Cycling control mechanism | microprocessor | | microprocessor | | Same |
| Power supply | Lithium battery 3.7V, 1200mAh | | RH-228: 5VDC, 1A (without battery)
RH-338: Lithium battery 3.7V, 850mAh | | Different |
| Suction strength (mmHg) | RH 668 | Mixed mode: 180-260 | RH 228 | Expression mode: 120-275 | Different |
| | | Stimulate mode: 90-190 | | | |
| | | Expression mode: 170-260 | | Stimulate mode: 60-150 | |
| | RH 708 | Mixed mode: 90-230 | RH 338 | Massage mode: 135-255 | |
| | | Stimulate mode: 90-220 | | Stimulate mode: 45-165 | |
| | | Expression mode: 140-260 | | | |
| | RH 718 | Mixed mode: 90-230 | | Expression mode: 110-300 | |
| | | Stimulate mode: 90-220 | | | |
| Expression mode: 160-270 | | | | | |
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| | RH 728 | Mixed mode: 160-240 | | |
| --- | --- | --- | --- | --- |
| | | Stimulate mode: 100-220 | | |
| | | Expression mode: 160-270 | | |
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| Cycle Speed (cycles/min) | RH 668 | Mixed mode: 48-60 | | Different | |
| --- | --- | --- | --- | --- | --- |
| | | Stimulate mode: 65-170 | | | |
| | | Expression mode: 23-76 | | | |
| | RH 708 | Mixed mode: 66-84 | RH 228 | | Expression mode: 28-52 |
| | | Stimulate mode: 49-78 | | | Stimulate mode: 58-90 |
| | | Expression mode: 27-56 | | | |
| | RH 718 | Mixed mode: 84-114 | RH 338 | | Massage mode: 56-72 |
| | | Stimulate mode: 51-170 | | | Stimulate mode: 115-155 |
| | | Expression mode: 25-50 | | | Expression mode: 25-52 |
| | RH 728 | Mixed mode: 60-78 | | | |
| | | Stimulate mode: 45-74 | | | |
| | | Expression mode: 26-51 | | | |
| Modes | RH 668: Mixed mode: 9 levels, Stimulate mode: 9 levels, Expression mode: 9 levels. RH 708: Mixed mode: 5 levels, Stimulate mode: 5 levels, Expression mode: 5 levels. RH 718: Mixed mode: 5 levels, Stimulate mode: 5 levels, Expression mode: 5 levels. RH 728: Mixed mode: 5 levels, Stimulate mode: 5 levels, Expression mode: 5 levels. | | RH 228: Expression mode: 4 levels, Stimulate mode: 5 levels. RH 338: Massage mode: 9 levels, Stimulate mode: 9 levels, Expression mode: 9 levels. | | Different |
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| User Interface | RH668
Increase suction level
Decrease suction level
on/off/change suction mode
mode indicator light and charging indicator light
current suction level | | Different |
| --- | --- | --- | --- |
| | RH708
suction level/battery level
increase suction level
decrease suction level
power/suction mode
indicator/charging indicator | RH228:
On/off
Change suction mode
Decrease suction level
Increase suction level | |
| | RH718
suction level/battery level
decrease suction level
increase suction level
power
suction mode indicator/charging indicator | RH338:
On/off
Change suction mode
Increase suction level
Decrease suction level | |
| | RH728
suction level/battery level
increase suction level
decrease suction level
power/suction mode
indicator/charging indicator | | |
| LED | LED | RH 228: LED
RH 338: LCD | Different |
| Flange size | 24 mm (for RH668, RH708, and RH728) | 26 mm | Different |
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| | 25.8 mm (for RH718) | | |
| --- | --- | --- | --- |
| Use-life | 2 years | 18 months | Different |
In comparison to the predicate device, the subject device has the same intended use and similar indications for use statements.
As seen in the comparison table, the subject and predicate devices have different technological features, including pump type (wearable vs hand-held), power source, vacuum/cycle speed specifications, available suction levels, modes available, user interface, flange size, and use-life. These technological differences do not raise different questions of safety and effectiveness.
## 7. Summary of Non-clinical Performance Testing
A series of safety and performance tests were conducted on the subject device.
All the test results demonstrate the Wearable Electric Breast Pump meets the requirements of its predefined acceptance criteria.
## Performance Verification
Bench performance testing was conducted to evaluate device performance:
- Vacuum pressure
- Cycle speed
- Backflow protection
- Battery capacity
- Operating time
- Charging time
## Use-Life Verification
Vacuum pressure, cycle speed and battery capacity were evaluated after conditioning equivalent to 2 years of use in the worst-case scenario.
## Biocompatibility testing
The biocompatibility evaluation for the Wearable Breast Pump was conducted 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,” as follows:
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- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2021)
- Irritation (ISO 10993-23:2021)
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
## Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted. The system complies with the following standards:
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance.
- 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,
- IEC 60601-1-2 :2014/A1:2021 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
- IEC 62133-2 :2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
## Software Verification and Validation Testing
Software verification and validation was conducted as recommended in the 2023 FDA guidance document, "Content of Premarket Submissions for Device Software Functions." with a Basic Documentation Level.
## 8. Substantial Equivalence Conclusion:
The results of the performance testing described above demonstrate that the Wearable Electric Breast Pump (RH 668, RH708, RH 718, RH728) is as safe and effective as the predicate device and supports a determination of substantial equivalence.
