K251754
- 510(k) number
- K251754
- Device name
- Wearable Breast Pump (Model S33)
- Applicant
- Shenzhen TPH Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-09-08
- Date received
- 2025-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251754.pdf
Official FDA record: K251754
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.