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EasyStand Evolv XT

by Altimate Medical, Inc.

Model Evolv XT

EasyStand Evolv XT is a device classified as Class I in the EU and Class II in the US made by Altimate Medical, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 0858921006V5FW), cleared under FDA 510(k) K062402 on 21 Sep 2006 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 10858921006024), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K062402

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0858921006V5FW Basic UDI-DI 10858921006024UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10858921006024 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK062402 Date21 Sep 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0858921006V5FW registered 21 Oct 2026 Active
  • FDA 510(k) K062402 decided 21 Sep 2006 Active
  • FDA GUDID UDI-DI 10858921006024 listed 19 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K062402
  2. Listed FDA GUDID 10858921006024
  3. Registered EUDAMED 0858921006V5FW

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  • Withdrawn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 · GUDID

Trade name
EasyStand Evolv XT EUDAMED
EasyStand GUDID
Generic name
Electric stander
Model / reference
Evolv XT
Primary DI / UDI-DI
10858921006024
Basic UDI-DI
0858921006V5FW
510(k) Number
FDA product code
INO
EMDN code
Y050202 Standing frames
GMDN term
Electric stander
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.3110
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Manual standerElectric stander

Cleared under the same submission (K062402)

Similar devices

Also classified as Electric stander.

Similar devices in this category

Other devices filed under STANDING FRAMES.

Other devices from Altimate Medical, Inc.

See all devices from Altimate Medical, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)