Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)— 510(k) K250843

Substantially Equivalent

Shenzhen TPH Technology Co., Ltd.

FDA 510(k) clearance K250843 for Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B), Substantially Equivalent on 2025-07-31. Applicant: Shenzhen TPH Technology Co., Ltd..

Clearance details

Applicant: Shenzhen TPH Technology Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-03-20
Decision date: 2025-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, 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.