Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)

K230776 · Shenzhen Lutejiacheng Technology Co., Ltd. · HGX · Jun 9, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K230776
• Device Name: Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
• Applicant: Shenzhen Lutejiacheng Technology Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Jun 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

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 Story

Momcozy Wearable Electric Breast Pump (S9 Pro, S12 Pro) is a powered, single-user device designed for milk expression. It operates via an electric motor to create suction, facilitating milk collection from lactating women. The device is intended for over-the-counter use by the patient. It functions as a wearable unit, allowing for hands-free operation during the expression process. The output is collected milk, which the user can then store or feed to an infant. The device provides a portable solution for breastfeeding mothers to maintain milk supply.

Technological Characteristics

Powered breast pump; wearable form factor; electric motor-driven suction; single-user design.

Indications for Use

Indicated for lactating women to express and collect 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.

Submission Summary (Full Text)

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June 9, 2023

Shenzhen Lutejiacheng Technology Co., Ltd. Athena Pan General Manager #2-2, Floor 2 Hasee Computer Building, No.2 Beier Rd, Bantian Street, Longgang Shenzhen, Guangdong 518129 China

Re: K230776

Trade/Device Name: Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: March 9, 2023 Received: March 21, 2023

Dear Athena Pan:

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 (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 located 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation -emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-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-device-advice-comprehensive-regulatoryassistance/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.

## 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

510(k) Number (if known) K230776

Device Name

Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro)

Indications for Use (Describe)

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.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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