Ningbo Baichen Medical Devices Co., Ltd.
Manufacturer and brand owner in Ningbo, Zhejiang, China. 4 device types, 4 products catalogued, 3 clearances.
Ningbo Baichen Medical Devices Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Crutch, Walker, Mechanical and 2 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
4device types registered with the FDA
4products catalogued under its own name
3510(k) clearances
Registration
| Registered name | NINGBO BAICHEN MEDICAL DEVICES CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3019842343 |
| FEI number | 3019842343 |
| DUNS | 707021891 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 宁波百辰医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Ningbo |
|---|---|
| Province | Zhejiang |
| Address | Room 2101, No.666 Taikang Middle Road, Yinzhou District |
| Postal code | 315000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Crutch | Class 1 | Crutches | 2025 | 112 |
| Vehicle, Motorized 3-Wheeled | Class 2 | Mobility Scooter (BC-MS310) | 2026 | 41 |
| Walker, Mechanical | Class 1 | Walking Cane | 2025 | 183 |
| Wheelchair, Powered | Class 2 | Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3), Power wheelchair | 2023 | 62 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252817 | 2026-01-02 | INI | Traditional | This company |
| K250475 | 2025-05-27 | ITI | Traditional | This company |
| K232121 | 2023-09-15 | ITI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Employees | 150 |
| Factory area | 20,000+ square meters |
| Main products | Electric wheelchairs, mobility scooters, carbon fiber wheelchairs |
| Certifications | CE, UKCA, FDA, ISO 9001, ISO 13485 |
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.