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K Number
K223693
Device Name
Electric breast pump (model: M5)
Manufacturer
Shenzhen Lutejiacheng Technology Co., Ltd.
Date Cleared
2023-03-09

(90 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Electric breast pump (model: M5) 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

Electric breast pump (model: M5)

AI/ML Overview

I am sorry, but this document is an FDA clearance letter for an electric breast pump. It does not contain information about acceptance criteria, device performance tables, sample sizes for test or training sets, details about ground truth establishment, or information about specific studies like MRMC or standalone algorithm performance.

Therefore, I cannot fulfill your request for that specific information based on the provided text.

§ 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).