Identity
- Device Name
- Electric Wheelchair EUDAMED
- Model / Reference
- ZW518 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974153925180 EUDAMED
- Basic UDI-DI
- 697415392ZW518PV EUDAMED
- 510(k) Number
- K243783 FDA 510(k)
- FDA Product Code
- IPL FDA 510(k)
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3900 FDA 510(k)
- Regulation Number
- 890.3900 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Electric Wheelchair by Shenzhen Zuowei Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K243783 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697415392ZW518PV | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zuowei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022824
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED bb93a33a-b050-4ba3-a494-b91b10b9eabb 61 fields · synced Jul 11, 2026
- FDA 510(k) K243783 24 fields · synced May 18, 2026