Electric Breast Pump

• K Number: K231595
• Device Name: Electric Breast Pump
• Manufacturer: Shenzhen Changkun Technology Co., Ltd.
• Date Cleared: 2023-10-26 ( 147 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

The Electric Breast Pump 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

The provided text is an FDA 510(k) clearance letter for an "Electric breast pump." This document details the regulatory clearance of a physical medical device, not a software-based AI/ML device.

Therefore, the information required to answer your query – acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment), and training set details – is not present in the provided text.

This document is a regulatory approval for a mechanical device and does not contain the kind of performance data and study design details typically found in submissions for AI/ML-driven diagnostic or assistive technologies.

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).