K253934
- 510(k) number
- K253934
- Device name
- Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-03-09
- Date received
- 2025-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253934.pdf
Official FDA record: K253934
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.