Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

• K Number: K243629
• Device Name: Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)
• Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.
• Date Cleared: 2024-12-20 ( 25 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Special
• Panel: OB
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Momcozy Wearable Breast Pump (Model: BP311, BP223, BP334, BP334, BP430) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Device Description

Not Found

AI/ML Overview

This document pertains to the FDA clearance of a medical device, specifically a breast pump. It does not contain information about the acceptance criteria or study details for an AI/ML-enabled medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-enabled device based on the provided text. The document is a standard FDA 510(k) clearance letter for a non-AI medical device.

Regulation Number and Section

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).