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Electric Wheelchair
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref YHW001-FModel YHW001-C、YHW001-D、YHW001-E、YHWL-002、YHWL-003
Identity
- Trade Name
- ZYGENAIR FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Electric Wheelchair EUDAMED
- Model / Reference
- YHW001-C、YHW001-D、YHW001-E、YHWL-002、YHWL-003 EUDAMEDYHW001-F EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974665663402 EUDAMEDFDA UDI
- Basic UDI-DI
- 697466566Y90WG EUDAMED
- 510(k) Number
- K240329 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electric Wheelchair by Yongkang Youha Electric Appliance Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240329 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697466566Y90WG | Class I | Active |
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Manufacturer
- Manufacturer
- Yongkang Youha Electric Appliance Co., Ltd
- EUDAMED SRN
- CN-MF-000035946
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 224dc6dd-c069-40e3-a6ae-b38ad8a07b2a 61 fields · synced Oct 7, 2026
- FDA UDI 15581ca1-bf26-404e-805e-ddeaaa2fd921 33 fields · synced May 30, 2026
- FDA 510(k) K240329 1 fields · synced May 18, 2026