K251394
- 510(k) number
- K251394
- Device name
- Momcozy Wearable Breast Pump (BP223)
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-09-08
- Date received
- 2025-05-05
- 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: K251394.pdf
Official FDA record: K251394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.