510(k) clearances

Eve

Wandercraft SAS · Physical Medicine

K260381Substantially EquivalentTraditionalPHL
Open FDA's page for this record
Third party flag
N
City
Paris
Advisory committee description
Physical Medicine
Address 1
88 Rue De Rivoli
Statement or summary
Summary
Product code
PHL
Zip code
75004
Applicant
Wandercraft SAS
Decision date
2026-08-03
Decision code
SESE
Country code
FR
Device name
Eve
Advisory committee
PM
Contact
Maria Ida Iacono
K number
K260381
Date received
2026-02-05
Review advisory committee
NE
Postal code
75004
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powered Exoskeleton
Medical specialty description
Physical Medicine
Regulation number
890.3480
Device class
2
Registration number
3011819880, 3018091330, 3009767053, 3015000676, 3034724466, 3007615665, 3014209670, 3009495988
FEI number
3011819880, 3018091330, 3009767053, 3015000676, 3034724466, 3007615665, 3014209670, 3009495988
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.