510(k) K253934 ยท HGX Pump, Breast, Powered
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., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 9, 2026 |
| Received | Dec 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253934
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.