K250152

eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;

510(k) number: K250152
Device name: eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;
Applicant: Shenzhen TPH Technology Co., Ltd. CN
Product code: HGX — Pump, Breast, Powered
Decision date: 2025-04-02
Date received: 2025-01-21
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Obstetrics/Gynecology

PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K250152.pdf

Official FDA record: K250152

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.