FDA-Device2025-05-14Class II
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
WANDERCRAFT SAS
Hazard
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Sold states
Domestic: PA & NY.
Affected count
3
Manufactured in
88 Rue De Rivoli, N/A, Paris, N/A, France
Products
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1739-2025Don't want to check this manually?
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