Shenzhen Root Innovation Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 8 device types, 3 products catalogued, 13 clearances.
Shenzhen Root Innovation Technology Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Shield, Nipple, Breast Pump Kit and 6 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021376102 |
| FEI number | 3021376102 |
| DUNS | 411899033 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 3301, Aerospace Innovation Building, No. 7013 Liuxian Avenue, Yuncheng Community, Xili Subdistrict |
| Postal code | 518071 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Binder, Abdominal | Class 1 | Momcozy Maternity Belt (Model: YB003), Momcozy Maternity Belt (Model: YB001,YB002); Momcozy Recovery Belly Belt (Model: RB001) | 2024 | 20 |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | Class 1 | Momcozy Wearable Breast Pump Accessories(Flange, Flange Cover, Milk Collector, Flange Insert) | 2024 | 10 |
| Breast Pump Kit | Class 2 | Momcozy Wearable Breast Pump kit(Flange, Valve, Milk Collector, Flange Insert, Flange Cover) | 2025 | 4 |
| Components, Exercise | Class 1 | MeggO Maternity Ball (Model: MeggO) | 2026 | 31 |
| Pump, Breast, Powered | Class 2 | Momcozy Wearable Breast Pump (BP380), Momcozy Wearable Breast Pump, Momcozy Wearable Breast Pump (BP311), Momcozy Wearable Breast Pump (Model S10); Momcozy Wearable Breast Pump (Model X1);, Momcozy Wearable Breast Pump (BP137, BP141), Momcozy Wearable Breast Pump (S9 Pro & S12 Pro ); and 4 more | 2022 | 40 |
| Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | Baby Nasal Aspirator (Model BN009), Baby Nasal Aspirator (Model BN006), Baby Nasal Aspirator (Model BN008), Momcozy Nasal Aspirator (Model BN007) | 2025 | 14 |
| Shield, Nipple | Class 1 | Silver Nipple Protective Cup(NS010) | 2026 | 15 |
| Stocking, Medical Support (For General Medical Purposes) | Class 1 | MoveWell Sports Compression Socks (Model: SO034), BambooFlex 3-in-1 Compression Socks (Model: SO016), MediStep Compression Socks (Model: SO033) | 2026 | 76 |
Own-Brand Listings
Clearances
13 clearances name Shenzhen Root Innovation Technology Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254254 | 2026-06-18 | HGX | Traditional | This company |
| K260538 | 2026-06-17 | HGX | Traditional | This company |
| K253629 | 2026-05-26 | BTA | Traditional | This company |
| K260134 | 2026-05-15 | BTA | Traditional | This company |
| K253914 | 2026-04-29 | HGX | Traditional | This company |
| K254258 | 2026-04-08 | HGX | Traditional | This company |
| K253946 | 2026-04-07 | HGX | Traditional | This company |
| K253934 | 2026-03-09 | HGX | Traditional | This company |
| K253283 | 2025-10-29 | HGX | Special | This company |
| K251394 | 2025-09-08 | HGX | Traditional | This company |
| K241680 | 2024-12-20 | HGX | Traditional | This company |
| K243629 | 2024-12-20 | HGX | Special | This company |
| K233880 | 2024-03-06 | HGX | Traditional | This company |
| K251450 | 2025-06-06 | BTA | Special | Shenzhen Desida Technology Co., Ltd. |
| K230776 | 2023-06-09 | HGX | Traditional | Shenzhen Lutejiacheng Technology Co., Ltd. |
| K223693 | 2023-03-09 | HGX | Traditional | Shenzhen Lutejiacheng Technology Co., Ltd. |
| K220309 | 2022-06-27 | HGX | Traditional | Shenzhen Lutejiacheng Technology Co., Ltd. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.