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EasyStand Bantam Extra Small

by Altimate Medical, Inc.

Model Bantam Extra Small

EasyStand Bantam Extra Small 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 20 Oct 2026 (Basic UDI-DI 0858921006V1FN), cleared under FDA 510(k) K091242 on 6 Jul 2009 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 10858921006079), active as of 24 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091242

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0858921006V1FN Basic UDI-DI 10858921006079UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10858921006079 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK091242 Date6 Jul 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0858921006V1FN registered 20 Oct 2026 Active
  • FDA 510(k) K091242 decided 6 Jul 2009 Active
  • FDA GUDID UDI-DI 10858921006079 listed 19 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0243-2023 FDA Class II initiated 4 Oct 2022

    Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine position.

Timeline

4 dated events

  1. Cleared FDA 510(k) K091242
  2. Listed FDA GUDID 10858921006079
  3. Recall initiated FDA recalls Z-0243-2023
  4. Registered EUDAMED 0858921006V1FN

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  • Withdrawn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 Bantam Extra Small EUDAMED
EasyStand GUDID
Generic name
Manual stander
Model / reference
Bantam Extra Small
Primary DI / UDI-DI
10858921006079
Basic UDI-DI
0858921006V1FN
510(k) Number
FDA product code
INO
EMDN code
Y050202 Standing frames
GMDN term
Manual stander
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.3110
EU registration type
Standard device
EU market of registration
Finland
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 standerPneumatic stander

Cleared under the same submission (K091242)

Similar devices

Also classified as Pneumatic 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)