Electric breast pump

• K Number: K212884
• Device Name: Electric breast pump
• Manufacturer: Dongguan Rongfeng Medical Co., Ltd.
• Date Cleared: 2022-01-20 ( 132 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Electric breast pump is intended to be used by lactating women to express and collect milk from their breast. It is intended for a single user.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for an "Electric breast pump." It discusses regulatory aspects, general controls, and indications for use.

However, it does not contain any information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), or training set details.

Therefore, I cannot extract the specific information you've requested regarding the study that proves the device meets acceptance criteria.

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).