FDA 510(k)

Atalante X

K 號：K250904 · 2025-10-24

決定日期2025-10-24

產品代碼PHL

諮詢委員會PM

決定相當於

器材摘要

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.

常見問題

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?

FDA 510(k) 記錄將Wandercraft SAS列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Atalante X?

The FDA product code for Atalante X is PHL.

其他以 Wandercraft SAS 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260381Eve K232077Atalante X K221859Atalante

相關器械（代碼：PHL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254198Trexo TheoTrexo Robotics, Inc.K260381EveWandercraft SAS K241822ReWalk® 7 個人外骨骼（50-20-0005）Rewalk Robotics Ltd. Dba Lifeward K233695醫學HAL下肢型（HAL-ML）Cyberdyne, Inc.K232077Atalante XWandercraft SAS K221696ReWalk P6.0Re Walk Robotics , Ltd.

官方來源

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