K250829
- 510(k) number
- K250829
- Device name
- Lacevo Wearable Breast Pump (Model S70)
- Applicant
- Shenzhen TPH Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-04-17
- Date received
- 2025-03-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250829.pdf
Official FDA record: K250829
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.