Momcozy Wearable Breast Pump (BP137/BP141) - FDA 510(k) Clearance

Device Information

Trade/Device Name: Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)

Regulation Number: 21 CFR 884.5160

Regulation Name: Powered Breast Pump

Regulatory Class: II

Product Code: HGX

Dated: December 8, 2023

Received: December 8, 2023

FDA Review and Determination

The U.S. Food & Drug Administration (FDA) has reviewed the section 510(k) premarket notification for the Momcozy Wearable Breast Pump (BP137 and BP141). The device has been determined to be substantially equivalent to legally marketed predicate devices. This clearance allows the device to be marketed subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (the Act).

The FDA notes that while the product is referred to as a device, some cleared products may be combination products. The 510(k) Premarket Notification Database can be accessed at accessdata.fda.gov.

General controls include requirements for annual registration, device listing, good manufacturing practice, and prohibitions against misbranding and adulteration. Device labeling must be truthful and not misleading.

Additional controls may apply if the device is classified into Class II (Special Controls) or Class III (PMA). Relevant regulations can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898.

Regulatory Guidance and Requirements

Information regarding changes that may require a new premarket notification is available in FDA guidance documents:

• "Deciding When to Submit a 510(k) for a Change to an Existing Device": FDA Guidance Document
• "Deciding When to Submit a 510(k) for a Software Change to an Existing Device": FDA Guidance Document

The device is subject to the Quality System (QS) regulation (21 CFR Part 820), including design controls, nonconforming product management, and corrective and preventive actions. Manufacturers must review and approve changes to device design and production and document these in the device master record.

FDA's substantial equivalence determination does not waive compliance with other Act requirements. Manufacturers must adhere to:

• Registration and listing (21 CFR Part 807)
• Labeling (21 CFR Part 801)
• Medical device reporting (adverse events) (21 CFR Part 803)
• Postmarketing safety reporting for combination products (21 CFR Part 4, Subpart B): FDA Information
• Good manufacturing practice requirements (21 CFR Part 820 for devices, 21 CFR Part 4, Subpart A for combination products)
• Electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Note the regulation "Misbranding by reference to premarket notification" (21 CFR 807.97).

For questions regarding adverse event reporting (MDR regulation), visit: FDA MDR Reporting.

For comprehensive regulatory information, consult Device Advice (FDA Device Advice) and CDRH Learn (FDA CDRH Learn).

Contact Information

For specific regulatory topics, contact the Division of Industry and Consumer Education (DICE):

• Website: FDA DICE Contact Information
• Email: DICE@fda.hhs.gov
• Phone: 1-800-638-2041 or 301-796-7100

Sincerely,

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

Indications for Use

Device Name: Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)

Indications for Use: The Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) 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: Over-The-Counter Use (21 CFR 801 Subpart C)

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