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FDA 510(k)

可攜式電刺激治療設備

K 號：K182020 · 2020-09-17

申請人Guangzhou Longest Science & Technology Co., Ltd.
決定日期2020-09-17
產品代碼NGX
諮詢委員會PM
決定相當於

器材摘要

Portable Electro-Stimulation Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-09-17 under 510(k) number K182020. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Portable Electro-Stimulation Therapy Device?

Portable Electro-Stimulation Therapy Device is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. The 510(k) number is K182020.

When did Portable Electro-Stimulation Therapy Device receive FDA 510(k) clearance?

Portable Electro-Stimulation Therapy Device received FDA 510(k) clearance on 2020-09-17, under 510(k) number K182020.

Who is the listed applicant for Portable Electro-Stimulation Therapy Device?

The FDA 510(k) record lists Guangzhou Longest Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Electro-Stimulation Therapy Device?

The FDA product code for Portable Electro-Stimulation Therapy Device is NGX.

相關臨床試驗

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其他以 Guangzhou Longest Science & Technology Co., 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。

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相關器械（代碼：NGX）

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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