LEVANT, HOMEGLIDE— 510(k) K121560

Name: FDA 510(k) clearance K121560
Creator: U.S. Food and Drug Administration
Published: 2012-11-01

Substantially Equivalent

Thyssenkrupp Accessibility B.V.

FDA 510(k) clearance K121560 for LEVANT, HOMEGLIDE, Substantially Equivalent on 2012-11-01. Applicant: Thyssenkrupp Accessibility B.V.. Device class: 2.

Clearance details

Applicant: Thyssenkrupp Accessibility B.V.
Product code: Code ILK
Device class: Class 2
Regulation: 21 CFR 890.5150
Advisory panel: Physical Medicine
Date received: 2012-05-29
Decision date: 2012-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zuid-Holland, NL

Download summary PDF View on FDA.gov ↗

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Recalls naming K121560

K-number listed on FDA's recall record

Z-0557-2013 — ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors.Class II·Terminated·ThyssenKrupp Access Corp·20120806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121560.

Data sourced from openFDA. This site is unofficial and independent of the FDA.