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Power Wheelchair
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref Q50 R CarbonModel N5513 N5513A N5515 N5515A N5516 N5516A W5517 N5517A N5519 W5521 W5521B N5525 W5526 W5536 W5536A W5536B W5538 N5901 W5905 W5905A W5907 Q50 R Carbon N5909 N5909A W5211 W5211B W5213 W5213C W5216 W5217 N5909D W5915B W5915D N5919
Identity
- Trade Name
- Power Wheelchair FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Power Wheelchair EUDAMED
- Model / Reference
- N5513 N5513A N5515 N5515A N5516 N5516A W5517 N5517A N5519 W5521 W5521B N5525 W5526 W5536 W5536A W5536B W5538 N5901 W5905 W5905A W5907 Q50 R Carbon N5909 N5909A W5211 W5211B W5213 W5213C W5216 W5217 N5909D W5915B W5915D N5919 EUDAMEDQ50 R Carbon EUDAMEDW5907(Q50 R Carbon) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970765971331 EUDAMEDFDA UDI
- Basic UDI-DI
- 697076597PW001QM EUDAMED
- 510(k) Number
- K220740 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
- Northern Ireland 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Power Wheelchair by Zhejiang Innuovo Rehabilitation Devices 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
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 | K231508 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K242471 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697076597PW001QM | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000008727
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 20dd640d-7d97-409a-8c80-4dcb538d45c3 61 fields · synced Jul 18, 2026
- FDA UDI f83ba80c-8ff7-4ba1-a888-5f3ba5a72d89 33 fields · synced May 29, 2026
- FDA 510(k) K231508 1 fields · synced May 18, 2026