Mobility Scooter
EUDAMEDFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- Mobility Scooter EUDAMED
- 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) W3431Q,W3431T,W3483,W3483A,W3483B,W3458G,W3431M,W3431U,W3489,W3470A,W3470B EUDAMEDW3481 EUDAMEDW3431B EUDAMEDW3431M EUDAMEDN3473A EUDAMEDW3431Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978949462422 EUDAMED06978949460299 EUDAMED06978949462569 EUDAMED06978949462484 EUDAMED06978949462644 EUDAMED06978949462668 EUDAMED06978949462552 EUDAMED
- Basic UDI-DI
- 697894946MS001W6 EUDAMED
- 510(k) Number
- K222507 FDA 510(k)
- FDA Product Code
- INI FDA 510(k)
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3800 FDA 510(k)
- Regulation Number
- 890.3800 FDA 510(k)
- Market of Registration
- Austria EUDAMEDSpain EUDAMEDGermany EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
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
This device is a mobility scooter, classified under nomenclature code Y122124, designed to assist individuals with limited mobility in indoor and outdoor environments. It provides powered propulsion for users who require enhanced mobility support, enabling greater independence and accessibility in daily activities.
The Mobility Scooter is a non-sterile, non-reusable, non-implantable device supplied in multiple model variants (e.g., W3331, W3481, W3902). It is intended for use in home, community, and public settings, with models including carbon-fiber options (e.g., W3902 S50 Carbon). Authorised under FDA 510K and MDR compliance, it is regulated as a Class I medical device with a Basic UDI of 697894946MS001W6.
Frequently asked questions
What types of environments is this mobility scooter designed to be used in, and how does that affect its suitability for different users?
The Mobility Scooter is explicitly designed for use in both indoor and outdoor settings, including homes, communities, and public spaces. This versatility makes it suitable for users who require mobility assistance in a variety of environments, such as navigating their home, shopping centers, or sidewalks. Its design ensures stability and maneuverability across different terrains, enhancing independence for individuals with limited mobility.
Are there different models available, and how do I determine which one might be best for my needs?
Yes, the Mobility Scooter comes in multiple model variants, including standard models like the W3481 and specialized options like the W3902 (S50 Carbon). The carbon-fiber variant (e.g., W3902 S50 Carbon) may offer lighter weight or enhanced durability, which could be preferable for users prioritizing portability or specific performance characteristics. Consulting with a healthcare provider or mobility specialist can help match your specific requirements—such as weight capacity, terrain needs, or indoor/outdoor use—to the most suitable model.
Is the Mobility Scooter reusable or single-use, and what does that mean for maintenance and cost over time?
The Mobility Scooter is classified as a non-reusable device, meaning it is intended for single-use or limited use by one individual. This classification implies that it is not designed to be cleaned, disinfected, or reused by multiple users, which simplifies maintenance but may impact long-term costs if replacements are needed. Users should follow manufacturer guidelines for care to ensure safe and effective use over its intended lifespan.
How should I store the Mobility Scooter when not in use, and are there any specific storage requirements?
Since the Mobility Scooter is non-sterile and non-reusable, storage should prioritize protection from environmental damage, such as moisture, extreme temperatures, or physical impacts. The manufacturer’s instructions (not provided here) should specify ideal storage conditions, but generally, keeping it in a dry, indoor space—preferably in its original packaging or a designated storage case—will help preserve its functionality. Avoid prolonged exposure to direct sunlight or damp areas.
What regulatory pathways does this device follow, and how does that affect its availability or compliance standards?
The Mobility Scooter is authorized under both FDA 510(k) and MDR (Medical Device Regulation) compliance, confirming it meets stringent safety and performance standards for medical devices in the U.S. and EU markets. As a Class I device, it is subject to general controls but does not require additional premarket approval beyond these pathways. This classification ensures it adheres to basic manufacturing and labeling requirements while being available for purchase through authorized distributors like SUNGO Europe B.V. (NL-AR-000000247).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220206 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K240012 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K242387 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K222507 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K240990 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697894946MS001W6 | 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 (8)
- EUDAMED 279194c4-95c3-4721-a22c-9c263f38edf2 61 fields · synced Sep 18, 2026
- EUDAMED ea8a6598-40dc-4e83-828b-69e2bcbb4278 61 fields · synced May 17, 2026
- EUDAMED 2e418b1a-a74a-44c8-8497-0cde73772764 61 fields · synced May 17, 2026
- EUDAMED efbe17fd-fda1-4c36-9774-fcc8293bedc6 61 fields · synced May 18, 2026
- FDA 510(k) K222507 24 fields · synced May 18, 2026
- EUDAMED f30590ef-6735-48b7-9aae-ee89e6397ccc 61 fields · synced Jul 11, 2026
- EUDAMED 5abe0807-8b49-4c78-9825-dac80e718d91 61 fields · synced Jul 25, 2026
- EUDAMED 610fc14c-7ba7-4795-99c6-ec3fa594d001 61 fields · synced Aug 3, 2026