K241004

Substantially Equivalent

Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)

Applicant: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Product code: HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2024-04-12
Decision date: 2024-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huizhou, 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.