510(k) Report

Devices descending from K250843

1 later device reach Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260346Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129…Polybell (Guangzhou) Limited20260—