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SupaScoota Motorized Vehicle - Spartan (Sumo) / Spartan SP (Sumo SP)

by Eurogreen International Inc.

510(k) K182631

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182631↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK182631 Date19 Sep 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
INI
FDA applicant
Eurogreen International, Inc.
Device Class
Class II
Regulation
21 CFR Part 890.3800
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SupaScoota Motorized Vehicle - Spartan (Sumo) and Spartan SP (Sumo SP) are three-wheeled motorized mobility aids designed for individuals with limited mobility. These devices provide powered assistance for indoor and outdoor navigation, enhancing independence and mobility for users requiring support beyond manual wheelchairs or walkers.

These motorized vehicles are intended for use in clinical and home settings, offering adjustable seating and control options tailored to user needs. Supplied as reusable devices, they undergo regulatory oversight under FDA 510K clearance and MDR compliance, ensuring adherence to safety and performance standards. The Spartan models are categorized under Class II medical devices, with specific model variants identified by their reference codes for inventory and regulatory tracking.

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