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Marvel Wheelchair, Model EDCAL01

by Rogue Wheels, Inc.

510(k) K082970

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) K082970↗

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 NumberK082970 Date12 Dec 2008ClearedStatusActive
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  • Withdrawn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
IOR
Device Class
Class I
Regulation
21 CFR Part 890.3850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Marvel Wheelchair, Model EDCAL01 is a mechanical, rigid, non-folding wheelchair. It consists of a main frame assembly, a caster wing assembly, a seating assembly, and large rear wheels.

This device is categorized under FDA class 1 and is subject to regulation number 890.3850. It is manufactured by Rogue Wheels, Inc. and has received FDA 510(k) clearance.

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the primary design of the Marvel Wheelchair, Model EDCAL01?

    The Marvel Wheelchair is a mechanical, rigid, non-folding device. It is constructed with a main frame assembly, a caster wing assembly, a seating assembly, and large rear wheels to provide a stable seating platform.

  • How is this device classified for regulatory purposes?

    This device is categorized as an FDA class 1 medical device under regulation number 890.3850. It has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to other legally marketed predicate devices.

  • Who is the manufacturer of the Marvel Wheelchair?

    The Marvel Wheelchair, Model EDCAL01 is manufactured by Rogue Wheels, Inc., located in Dundas, Canada.