Baichen
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Baichen FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Electric Wheelchair EUDAMED
- Model / Reference
- BC-EA8000; BC-EA7001; BC-EA8001; BC-EA8002; BC-EA8003; BC-EA8004; BC-EA8005; BC-EA8006; BC-EA8007; BC-EA8008; BC-EA8009; BC-EA8010; BC-EA9000; BC-EA5521; BC-EC01;BC-EC02;BC-EA5515; BC-EA530; BC-EA5513; BC-EALD3; BC-ES6001; BC-ES6003,etc EUDAMEDBC-EA8009 EUDAMEDSonix BC-EA8000-530 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975185620104 EUDAMEDFDA UDI
- Basic UDI-DI
- 697518562ewheelchair001YK EUDAMED
- 510(k) Number
- K250475 FDA UDI
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electric-motor-driven wheelchair, occupant-controlled
Baichen by Ningbo Baichen Medical Devices Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electric-motor-driven wheelchair, occupant-controlled.
- YOUHUAN — Ningbo Youhuan Automation Technology Co., Ltd · Class II
- WHILL, Inc. — WHILL, INC. · Class II
- Permobil — PERMOBIL, INC. · Class II
- MODULAR POWER POSITIONING SYSTEM — Motion Concepts Inc · Class II
- XSTO — XSTO CO., LTD. · Class II
- INVACARE® TDX® POWER WHEELCHAIR — Invacare Corp. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- Merits — MERITS HEALTH PRODUCTS., INC. · Class II
Cleared under the same submission
K250475 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Baichen Medical Devices Co., Ltd
Sources (2)
- FDA UDI c1a53b61-ffe4-4665-b8d0-d1b967af3c32 33 fields · synced Jun 11, 2026
- EUDAMED f897152f-8aba-4b2f-b532-4f8152921f53 61 fields · synced Jun 11, 2026