K253914
- 510(k) number
- K253914
- Device name
- Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-04-29
- Date received
- 2025-12-08
- 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: K253914.pdf
Official FDA record: K253914
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.