Data / Medical devices / China / Linhejiacheng (shenzhen) E-Commerce Co., Ltd.
Linhejiacheng (shenzhen) E-Commerce Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Linhejiacheng (shenzhen) E-Commerce Co., Ltd. is registered with the FDA (registration 3038296449) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038296449
- Address
- Unit A1, Room 201, Building 1, Yinzhixing Life and Health Technology Park, Fenghuang Community, Fenghuang Street, Guangming District, Shenzhen Guangdong, China, 518132
- Owner or operator
- Linhejiacheng (Shenzhen) E-commerce Co., Ltd. (10093242)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 14, 2025
- Registered through
- 2026
- Brand names listed
- Paruu Wearable Breast Pump (Model: M1), Paruu Wearable Breast pump P16, P16-A, P16-B, P20, P10, P10 PRO, P21, Silicone Nipple Protective Cup(Model: NP01), Silver Nipple Protective Cup(Model: NS100, NS101)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Powered | HGX | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Shield, Nipple | HFS | 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 |
|---|---|---|---|---|---|---|
| December 23, 2025 | K253072 | Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) | HGX | Substantially Equivalent | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | accessdata.fda.gov |
| September 11, 2024 | K241004 | Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) | HGX | Substantially Equivalent | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 23, 2025. 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.