K254258
- 510(k) number
- K254258
- Device name
- Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-04-08
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K254258.pdf
Official FDA record: K254258
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.