K250207

Substantially Equivalent

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

Applicant: Anker Innovations Limited
Product code: HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-01-24
Decision date: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, 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.