Atlas FDA

LEVANT, HOMEGLIDE

FDA 510(k) clearance K121560 · decided 2012-11-01

Clearance details

K-number
K121560
Device name
LEVANT, HOMEGLIDE
Applicant
Thyssenkrupp Accessibility B.V.
Decision
Substantially Equivalent
Date received
2012-05-29
Decision date
2012-11-01
Days to decision
156 days
Clearance type
Traditional
Product code
ILK
Device class
2
Regulation number
890.5150
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Zuid-Holland, NL
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobili recall (Z-0557-2013)ThyssenKrupp Access Corp2012-12-18