510(k) K253946 ยท HGX Pump, Breast, Powered
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)
| Applicant | Shenzhen Root Innovation Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 7, 2026 |
| Received | Dec 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253946
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.