Shenzhen Root Innovation Technology Co., Ltd.
Medical device manufacturer in Shenzhen, CN.
13510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional | 06/18/2026SE |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX · Traditional | 06/17/2026SE |
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | 05/26/2026SE |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | 05/15/2026SE |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)HGX · Traditional | 04/29/2026SE |
| K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A…HGX · Traditional | 04/08/2026SE |
| K253946 | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A…HGX · Traditional | 04/07/2026SE |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)HGX · Traditional | 03/09/2026SE |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-…HGX · Special | 10/29/2025SE |
| K251394 | Momcozy Wearable Breast Pump (BP223)HGX · Traditional | 09/08/2025SE |
| K243629 | Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy…HGX · Special | 12/20/2024SE |
| K241680 | Momcozy Wearable Breast Pump (BP311)HGX · Traditional | 12/20/2024SE |
| K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)HGX · Traditional | 03/06/2024SE |