FDA 510(k)

HAL用於醫療（下肢型）

K 號：K171909 · 2017-12-17

決定日期2017-12-17

產品代碼PHL

諮詢委員會PM

決定相當於

器材摘要

HAL for Medical Use (Lower Limb Type) is the device name listed in this FDA 510(k) record. The listed applicant is Cyberdyne, Inc.. It received FDA 510(k) clearance on 2017-12-17 under 510(k) number K171909. 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 HAL for Medical Use (Lower Limb Type)?

HAL for Medical Use (Lower Limb Type) is a medical device that received FDA 510(k) clearance on 2017-12-17. The listed applicant is Cyberdyne, Inc.. The 510(k) number is K171909.

When did HAL for Medical Use (Lower Limb Type) receive FDA 510(k) clearance?

HAL for Medical Use (Lower Limb Type) received FDA 510(k) clearance on 2017-12-17, under 510(k) number K171909.

Who is the listed applicant for HAL for Medical Use (Lower Limb Type)?

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

What is the FDA product code for HAL for Medical Use (Lower Limb Type)?

The FDA product code for HAL for Medical Use (Lower Limb Type) is PHL.

其他以 Cyberdyne, Inc. 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。

K233695醫學HAL下肢型（HAL-ML）K201559HAL用於醫療（下肢型）

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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