K242725

Substantially Equivalent

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

Applicant: Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Product code: HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2024-09-10
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cixi, 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.