ClearanceBrief
510(k) K250843 ยท HGX Pump, Breast, Powered

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)

ApplicantShenzhen TPH Technology Co., Ltd., Shenzhen, CN
DecisionSubstantially Equivalent, Jul 31, 2025
ReceivedMar 20, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K250843

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.