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Levant, Homeglide

by Thyssenkrupp Accessibility B.V.

510(k) K121560

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121560 Date1 Nov 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0557-2013 FDA Class II initiated 6 Aug 2012

    The seat could break as a result of damage resulting from a seat belt being trapped underneath the foldable part of the seat when the seat belt is not buckled.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ILK
Device Class
Class II
Regulation
21 CFR Part 890.5150
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from Thyssenkrupp Accessibility B.V.

  • FLOW2, Swing

    Class II