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Mobility Scooter

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref W3481Model 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,W3470BRef W3431BRef W3431M510(k) K222507Ref N3473ARef W3431Q

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

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 EUDAMED
W3481 EUDAMED
W3431B EUDAMED
W3431M EUDAMED
N3473A EUDAMED
W3431Q EUDAMED

Identifiers

Primary DI / UDI-DI
06978949462422 EUDAMED
06978949460299 EUDAMED
06978949462569 EUDAMED
06978949462484 EUDAMED
06978949462644 EUDAMED
06978949462668 EUDAMED
06978949462552 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 EUDAMED
Class 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 EUDAMED
Spain EUDAMED
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

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

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

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