Data / Medical devices / China / Jiangsu Xinbei Electrical Appliances CO., LTD.
Jiangsu Xinbei Electrical Appliances CO., LTD.: FDA-registered device maker in Wuxi Jiangsu, China, 4 510(k) clearances
Jiangsu Xinbei Electrical Appliances CO., LTD. is registered with the FDA (registration 3010334650) in Wuxi Jiangsu, China. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 9, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010334650
- Address
- NO. 115 Xinjin Road, Xinwu District, Wuxi Jiangsu, China, 214000
- Owner or operator
- Jiangsu Xinbei Electrical Appliances Co., Ltd (10048891)
- Roles
- Contract manufacturer, Foreign private label distributor, Manufacturer
- First device listed
- March 17, 2015
- Registered through
- 2027
- Brand names listed
- BB BREAST MASSAGER 423667, BB BREAST PUMP 3, BB BREAST PUMP V2 NO ROLLERBALL, BB WEARABLE DOUBLE BREAST PUMP, BabyBuddha Breast Pump, BabyBuddha breast pump 2., Electric Breast Pump XB-8132, XB-8782, XB-8159, XB-8786, Gradient Compression Socks and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Binder, Medical, Therapeutic | MDR | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Contract manufacturer, Foreign private label distributor, 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 9, 2022 | K221598 | Wearable breast pump | HGX | Substantially Equivalent | Mayborn (Uk) Limited | accessdata.fda.gov |
| August 26, 2021 | K202802 | TT Electric Breast Pump, TT Double Electric Breast Pump | HGX | Substantially Equivalent | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | accessdata.fda.gov |
| December 21, 2015 | K151284 | Electric Double Breast Pumps | HGX | Substantially Equivalent | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | accessdata.fda.gov |
| February 24, 2015 | K142479 | MEGNA BREAST PUMPS | HGX | Substantially Equivalent | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Pad, Menstrual, Unscented
- All makers of Binder, Medical, Therapeutic
- All makers of Accessory, Surgical Apparel
- All makers of Massager, Therapeutic, Electric
- All makers of Pump, Breast, Non-Powered
Updated December 9, 2022. 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.