Data / Medical devices / China / Shenzhen Root Innovation Technology Co., Ltd.
Shenzhen Root Innovation Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 14 510(k) clearances
Shenzhen Root Innovation Technology Co., Ltd. is registered with the FDA (registration 3021376102) in Shenzhen Guangdong, China. It lists 10 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 17, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021376102
- Address
- Room 3301, Aerospace Innovation Building, No. 7013 Liuxian Avenue, Yuncheng Community, Xili Subdistrict Nanshan District, Shenzhen Guangdong, China, 518071
- Owner or operator
- Shenzhen Root Innovation Technology Co., Ltd. (10083690)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 29, 2022
- Registered through
- 2027
- Brand names listed
- Baby Nasal Aspirator (Model BN006), Baby Nasal Aspirator (Model BN008), Baby Nasal Aspirator (Model BN009), BambooFlex 3-in-1 Compression Socks (Model: SO016), MediStep Compression Socks (Model: SO033), MeggO Maternity Ball (Model: MeggO), Momcozy LumiRestore Red Light Therapy Device (Model: Lumi1), Momcozy Maternity Belt (Model: YB001,YB002); Momcozy Recovery Belly Belt (Model: RB001) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Binder, Abdominal | FSD | 1 | Manufacturer | accessdata.fda.gov |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | 1 | Manufacturer | accessdata.fda.gov |
| Breast Pump Kit | OHH | 2 | Manufacturer | accessdata.fda.gov |
| Components, Exercise | IOD | 1 | Manufacturer | accessdata.fda.gov |
| Heater, Perineal, Direct Contact | HGZ | 2 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 17, 2026 | K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | HGX | Substantially Equivalent | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| May 26, 2026 | K253629 | Momcozy Nasal Aspirator (BN007) | BTA | Substantially Equivalent | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| May 15, 2026 | 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 | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| April 8, 2026 | 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 | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| April 7, 2026 | 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 | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| March 9, 2026 | K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | HGX | Substantially Equivalent | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| October 29, 2025 | K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | HGX | Substantially Equivalent | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| September 8, 2025 | K251394 | Momcozy Wearable Breast Pump (BP223) | HGX | Substantially Equivalent | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| June 6, 2025 | K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | BTA | Substantially Equivalent | Shenzhen Desida Technology Co., Ltd. | accessdata.fda.gov |
| December 20, 2024 | K241680 | Momcozy Wearable Breast Pump (BP311) | HGX | Substantially Equivalent | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| March 6, 2024 | K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) | HGX | Substantially Equivalent | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| June 9, 2023 | K230776 | Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | HGX | Substantially Equivalent | Shenzhen Lutejiacheng Technology Co., Ltd. | accessdata.fda.gov |
| March 9, 2023 | K223693 | Electric breast pump (model: M5) | HGX | Substantially Equivalent | Shenzhen Lutejiacheng Technology Co., Ltd. | accessdata.fda.gov |
| June 27, 2022 | K220309 | Wearable Breast Pump (Model S10) | HGX | Substantially Equivalent | Shenzhen Lutejiacheng Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Components, Exercise
- All makers of Breast Pump Kit
- All makers of Binder, Abdominal
- All makers of Shield, Nipple
- All makers of Heater, Perineal, Direct Contact
Updated June 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.