Device product

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.

Z-1739-2025

April 03, 2025

Class II

Product summary

Firm: WANDERCRAFT SAS
Event: Event 96635
Status: Ongoing
Classification: Class II
Quantity: 3
Official record key: device-enforcement:Z-1739-2025

Official wording

Reason: Potential for exoskeleton to lose lateral balance and cause patient to fall.

Code information: UDI: (01)3665965000129(21)V5_ABP(11)AA06JJ, (01)3665965000129(21)V5_ACH(11)AA09JJ, (01)3665965000129(21)V5_ADO(11)AA02JJ. No model or serial number.

Distribution pattern: Domestic: PA & NY.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential for exoskeleton to lose lateral balance and cause patient to fall.