FDA 510(k)

ReWalk Restore

K 號：K190337 · 2019-06-03

決定日期2019-06-03

產品代碼PHL

諮詢委員會PM

決定相當於

器材摘要

ReWalk Restore is the device name listed in this FDA 510(k) record. The listed applicant is Re Walk Robotics , Ltd.. It received FDA 510(k) clearance on 2019-06-03 under 510(k) number K190337. 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 ReWalk Restore?

ReWalk Restore is a medical device that received FDA 510(k) clearance on 2019-06-03. The listed applicant is Re Walk Robotics , Ltd.. The 510(k) number is K190337.

When did ReWalk Restore receive FDA 510(k) clearance?

ReWalk Restore received FDA 510(k) clearance on 2019-06-03, under 510(k) number K190337.

Who is the listed applicant for ReWalk Restore?

The FDA 510(k) record lists Re Walk Robotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReWalk Restore?

The FDA product code for ReWalk Restore is PHL.

其他以 Re Walk Robotics , Ltd. 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。

K221696ReWalk P6.0 K200032ReWalk P6.0

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 K250904Atalante XWandercraft 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

官方來源

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