Ameda GLO Wearable Breast Pump (Model W8S)— 510(k) K250463

Substantially Equivalent

Shenzhen TPH Technology Co., Ltd.

FDA 510(k) clearance K250463 for Ameda GLO Wearable Breast Pump (Model W8S), Substantially Equivalent on 2025-03-20. Applicant: Shenzhen TPH Technology Co., Ltd..

Clearance details

Applicant: Shenzhen TPH Technology Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-02-18
Decision date: 2025-03-20
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.