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Shenzhen Root Innovation Technology Co., Ltd.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories2
Latest FDA decision2026-06-18
TypeNumberDevice NameCodeDateActions
510(k) K254254 Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX2026-06-18 View
510(k) K260538 Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX2026-06-17 View
510(k) K253629 Momcozy Nasal Aspirator (BN007)BTA2026-05-26 View
510(k) K260134 Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)BTA2026-05-15 View
510(k) K253914 Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)HGX2026-04-29 View
510(k) K254258 Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)HGX2026-04-08 View
510(k) K253946 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)HGX2026-04-07 View
510(k) K253934 Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)HGX2026-03-09 View
510(k) K253283 Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)HGX2025-10-29 View
510(k) K251394 Momcozy Wearable Breast Pump (BP223)HGX2025-09-08 View
510(k) K241680 Momcozy Wearable Breast Pump (BP311)HGX2024-12-20 View
510(k) K233880 Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)HGX2024-03-06 View
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