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Twist

by KLAXON MOBILITY GmbH

Ref KT025102, KR025104, KR025100, KT025106, KR025105, KT025100, KT025104-US2Model TWIST510(k) K250748

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250748↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number918000246TWIST2022HF Basic UDI-DI Date25 Sep 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK250748 Date11 Apr 2025ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
TWIST, KT025102, KR025104, KR025100, KT025106, KR025105, KT025100, KT025104-US2
Primary DI / UDI-DI
09180002464053, 09180002463780, 09180002463797, 09180002464077, 09180002464091, 09180002463773, 09180002464510
Basic UDI-DI
918000246TWIST2022HF
510(k) Number
FDA Product Code
ITI
EMDN Code
Y122499 Wheelchairs accessories - other
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 890.3860
EU market of registration
Austria
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

Manufacturer details

EUDAMED SRN
AT-MF-000004590

Other devices from Klaxon Mobility GmbH

See all devices from Klaxon Mobility GmbH →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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