Jiangsu Xinbei Electrical Appliances Co., Ltd.
Registered establishment in Wuxi, Jiangsu, China. 6 device types.
Jiangsu Xinbei Electrical Appliances Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pump, Breast, Powered, Pad, Menstrual, Unscented and 4 other device types. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | Jiangsu Xinbei Electrical Appliances CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010334650 |
| FEI number | 3010334650 |
| Establishment type | Contract manufacturer, Private-label distributor, Manufacturer |
Chinese Registration
| Chinese legal name | 江苏新贝电器有限公司 |
|---|---|
| Source | Aiqicha company register |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | NO. 115 Xinjin Road, |
| Postal code | 214000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | KN95 Protective Face Mask | 2020 | 439 |
| Binder, Medical, Therapeutic | Class 1 | Postpartum Recovery Support Garment for C Section, Pregnancy Support Band, Postpartum Recovery Support Garment, Gradient Compression Socks | 2019 | 2 |
| Massager, Therapeutic, Electric | Class 1 | BB Breast Massager 423667, Lactation Massager XB-9228, XB-9229, Lactation Massager TCG-003, Massager TCG-001 | 2020 | 437 |
| Pad, Menstrual, Unscented | Class 1 | Model: ZPPRS Zomee Zomee Postpartum Recovery System | 2024 | 132 |
| Pump, Breast, Non-Powered | Class 1 | Silicone Breast Pump, Manual Breast Pump XB-8610, Manual Breast Pump XB-8639, Manual Breast Pump XB-8612, Manual Breast Pump XB-8611, Motif Collection CUP Resupply and 28 more | 2015 | 33 |
| Pump, Breast, Powered | Class 2 | NCVI Wearable Breast Pump AM8111, AM8131, AM8161, AM8168, AM8791, AM3105, AM3110, AM8786, TT Wearable Breast Pump 1203, Wearable Breast Pump XB-8111, XB-8131, XB-8133, XB-8161, XB-8168, XB-8791, TT Electric Breast Pump, Model:1183, TT Electric Breast Pump, Model:1162, electric breast pump MDS68000,MDS68010 and 19 more | 2015 | 40 |
Clearances
No clearance names Jiangsu Xinbei Electrical Appliances 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 |
|---|---|---|---|---|
| K221598 | 2022-12-09 | HGX | Traditional | Mayborn (UK) Limited |
| K202802 | 2021-08-26 | HGX | Traditional | Wuxi Xinzhongrui Baby Supplies Co., Ltd. |
| K151284 | 2015-12-21 | HGX | Traditional | Wuxi Xinzhongrui Baby Supplies Co., Ltd. |
| K142479 | 2015-02-24 | HGX | Traditional | Wuxi Xinzhongrui Baby Supplies 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.