FDA 510(k)

HAL用於醫療（下肢型）

K 號：K201559 · 2020-10-02

決定日期2020-10-02

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 2020-10-02 under 510(k) number K201559. 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 2020-10-02. The listed applicant is Cyberdyne, Inc.. The 510(k) number is K201559.

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 2020-10-02, under 510(k) number K201559.

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。

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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。

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官方來源

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