K222782

Substantially Equivalent

Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)

Applicant: Zhejiang Carebao Co., Ltd.
Product code: HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2022-09-15
Decision date: 2023-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, 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.