510(k) K261025— Wearable breast pump (QY-101, QY-102, QY-108)

Substantially Equivalent

Shenzhen Qinyi Electronic Technology Co., Ltd.

Clearance details

Applicant: Shenzhen Qinyi Electronic Technology Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2026-03-30
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.