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Rollz Motion Electric 2M

by Rollz International BV EUDAMED510(k)

Active European Union and United States

510(k) K250819Ref 2010RE0002

Overview

The Rollz Motion Electric 2M is a Powered Wheelchair, classified as a Class II medical device under FDA regulations. It is designed to provide mobility assistance for individuals requiring electric propulsion, featuring a lightweight and compact structure for enhanced maneuverability and ease of transport. This device is intended for indoor and outdoor use on various terrains, including sidewalks, paved streets, and compacted surfaces, while maintaining stability and control for the user.

This wheelchair is supplied as a reusable, non-sterile device, intended for individual patient use. It is not MRI-compatible and must be stored in a dry, well-ventilated environment when not in use. The Rollz Motion Electric 2M has received FDA 510K clearance and MDR authorization, confirming compliance with regulatory standards for powered mobility devices. The device is manufactured by Rollz International BV, based in Delft, Netherlands.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250819 Date7 Nov 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number2090425RollzMotionEZJ Basic UDI-DIDate16 Jan 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

Full name
Electric Wheelchair (Rollz Motion Electric 2M)
Trade Name
Rollz Motion Electric
Model / Reference
2010RE0002
Primary DI / UDI-DI
08718347123406
Basic UDI-DI
2090425RollzMotionEZJ
Direct Marketing DI
08718347123406
510(k) Number
FDA Product Code
ITI
EMDN Code
Y120609,Y122127
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 890.3860
Market of Registration
Netherlands
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

Questions

  • Is the Rollz Motion Electric 2M wheelchair designed for both indoor and outdoor use, and what types of surfaces can it handle?

    Yes, the Rollz Motion Electric 2M is explicitly designed for both indoor and outdoor use. It is engineered to navigate various terrains, including sidewalks, paved streets, and compacted surfaces, while maintaining stability and control for the user.

  • How should I store the Rollz Motion Electric 2M when it is not in use, and is it safe to use in an MRI environment?

    The Rollz Motion Electric 2M must be stored in a dry, well-ventilated environment when not in use. Importantly, this device is not MRI-compatible, so it should never be taken into an MRI scanner.

  • Is the Rollz Motion Electric 2M a single-use or reusable device, and what does that mean for maintenance?

    The Rollz Motion Electric 2M is a reusable device intended for individual patient use. This means it is designed to be cleaned and maintained for long-term use by the same patient, rather than being discarded after a single use.

  • What regulatory approvals does the Rollz Motion Electric 2M have, and how does that affect its availability?

    The Rollz Motion Electric 2M has received FDA 510(k) clearance and MDR authorization, confirming compliance with regulatory standards for powered mobility devices in the U.S. and EU markets, respectively. These approvals validate its safety and performance for use as described.

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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