FDA 510(k)

Atalante X

K-Number: K250904 · 2025-10-24

Decision Date2025-10-24

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Atalante X is the device name listed in this FDA 510(k) record. The listed applicant is Wandercraft SAS. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K250904. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atalante X?

Atalante X is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Wandercraft SAS. The 510(k) number is K250904.

When did Atalante X receive FDA 510(k) clearance?

Atalante X received FDA 510(k) clearance on 2025-10-24, under 510(k) number K250904.

Who is the listed applicant for Atalante X?

The FDA 510(k) record lists Wandercraft SAS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atalante X?

The FDA product code for Atalante X is PHL.

Other records listing Wandercraft SAS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260381Eve K232077Atalante X K221859Atalante

Related Devices (Code: PHL)

K260381EveWandercraft SAS K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba Lifeward K233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SAS K221696ReWalk P6.0Re Walk Robotics , Ltd.K221859AtalanteWandercraft SAS

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.