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)— 510(k) K243629

Substantially Equivalent

Shenzhen Root Innovation Technology Co., , Ltd.

FDA 510(k) clearance K243629 for 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), Substantially Equivalent on 2024-12-20. Applicant: Shenzhen Root Innovation Technology Co., , Ltd..

Clearance details

Applicant: Shenzhen Root Innovation Technology Co., , Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2024-11-25
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.