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Found 2 results

510(k) Data Aggregation

K Number

Device Name

Momcozy Wearable Breast Pump (BP223)

Manufacturer

Shenzhen Root Innovation Technology Co., Ltd.

Date Cleared

2025-09-08

(126 days)

Product Code

Regulation Number

Type

Panel

Obstetrics and Gynecology (OB)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

Momcozy Wearable Breast Pump (BP223)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

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

Regulation Number

Type

Panel

Obstetrics and Gynecology (OB)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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.

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