Data / Medical devices / China / Ningbo Baichen Medical Devices Co., Ltd
Ningbo Baichen Medical Devices Co., Ltd: FDA-registered device maker in Ningbo City Zhejiang, China, 3 510(k) clearances
Ningbo Baichen Medical Devices Co., Ltd is registered with the FDA (registration 3019842343) in Ningbo City Zhejiang, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019842343
- Address
- Room 2101, No.666 Taikang Middle Road, Yinzhou District, Ningbo City Zhejiang, China, 315000
- Owner or operator
- Ningbo Baichen Medical Devices Co., Ltd (10088801)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 12, 2023
- Registered through
- 2026
- Brand names listed
- Crutches, Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3), Mobility Scooter (BC-MS310), Power wheelchair, Walking Cane
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crutch | IPR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Vehicle, Motorized 3-Wheeled | INI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 2, 2026 | K252817 | Mobility Scooter (BC-MS310) | INI | Substantially Equivalent | Ningbo Baichen Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 27, 2025 | K250475 | Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) | ITI | Substantially Equivalent | Ningbo Baichen Medical Devices Co., Ltd. | accessdata.fda.gov |
| September 15, 2023 | K232121 | Power wheelchair (Model:BC-EA8000) | ITI | Substantially Equivalent | Ningbo Baichen Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Powered
- All makers of Walker, Mechanical
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Crutch
Updated January 2, 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.