510(k) K254254 ยท HGX Pump, Breast, Powered
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
| Applicant | Shenzhen Root Innovation Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 18, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254254
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.