Shenzhen Root Innovation Technology Co., Ltd.
Shenzhen Guangdong, CN
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Shenzhen Root Innovation Technology Co., Ltd. between 2024 and 2026. The busiest year on record is 2026, with 8. The most recent is 2026, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | HGX | Substantially Equivalent | |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | HGX | Substantially Equivalent | |
| K253629 | Momcozy Nasal Aspirator (BN007) | BTA | Substantially Equivalent | |
| 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) | BTA | Substantially Equivalent | |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | HGX | Substantially Equivalent | |
| 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) | HGX | Substantially Equivalent | |
| 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) | HGX | Substantially Equivalent | |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | HGX | Substantially Equivalent | |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | HGX | Substantially Equivalent | |
| K251394 | Momcozy Wearable Breast Pump (BP223) | HGX | Substantially Equivalent | |
| K243629 | Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430) | HGX | Substantially Equivalent | |
| K241680 | Momcozy Wearable Breast Pump (BP311) | HGX | Substantially Equivalent | |
| K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) | HGX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3021376102 | 3021376102 | SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD. | Room 3301, Aerospace Innovation Building, No. 7013 Liuxian Avenue, Yuncheng Community, Xili Subdistrict, Shenzhen Guangdong 518071 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain