Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)— 510(k) K242725

Substantially Equivalent

Ningbo Youhe Electrical Appliance Technology Co., Ltd.

FDA 510(k) clearance K242725 for Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s), Substantially Equivalent on 2025-05-30. Applicant: Ningbo Youhe Electrical Appliance Technology Co., Ltd..

Clearance details

Applicant: Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Product code: 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

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.