K252192

Substantially Equivalent

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)

Applicant: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Product code: HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-07-14
Decision date: 2025-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Huizhou, CN

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.