Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)

• K Number: K233880
• Device Name: Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
• Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.
• Date Cleared: 2024-03-06 ( 89 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

The Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) is a powered breast pump 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 document is a 510(k) clearance letter from the FDA for the Momcozy Wearable Breast Pump (BP137) and Momcozy Wearable Breast Pump (BP141).

This type of document does not contain the information requested regarding acceptance criteria and performance studies. 510(k) clearance letters primarily state that the FDA has determined the device is substantially equivalent to a legally marketed predicate device and outline regulatory requirements.

Information about specific performance studies, acceptance criteria, sample sizes, expert qualifications, and ground truth establishment is typically found in the 510(k) premarket notification submission itself, which is not included in this letter.

Therefore, I cannot provide answers to the questions based on the given text.

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).