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Mobility Scooter
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref W3331Model W3331 W3431 W3431B W3431D W3433 W3433D W3433E W3435 W3451 N3458 N3458A N3458C W3459 W3463 W3463A W3467 N3473 W3901 W3465 W3481 N3473A N3473C W3902(S50 Carbon)510(k) K240008
Identity
- Trade Name
- Mobility scooter FDA UDI
- Generic Name
- Assistive three-wheeled moped FDA UDI
- Device Name
- Mobility Scooter EUDAMED
- Model / Reference
- W3331 W3431 W3431B W3431D W3433 W3433D W3433E W3435 W3451 N3458 N3458A N3458C W3459 W3463 W3463A W3467 N3473 W3901 W3465 W3481 N3473A N3473C W3902(S50 Carbon) EUDAMEDW3331 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970765970006 EUDAMEDFDA UDI
- Basic UDI-DI
- 697076597MS001NQ EUDAMED
- 510(k) Number
- K062676 FDA UDI
- FDA Product Code
- INI FDA UDI
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
- GMDN Term
- Assistive three-wheeled moped FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3800 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mobility Scooter 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240008 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697076597MS001NQ | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000008727
- FDA Applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 9f3a1bb0-79b6-41da-a222-12057ad3ab6d 85 fields · synced Jun 18, 2026
- FDA UDI 087e1f11-5558-4363-b9a2-242178c578a5 33 fields · synced May 30, 2026
- FDA 510(k) K240008 1 fields · synced May 18, 2026