FDA 510(k)

經皮電神經刺激器型號：ST-304

K 號：K221092 · 2022-09-13

決定日期2022-09-13

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Transcutaneous Electrical Nerve Stimulator Model: ST-304 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Future Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K221092. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Transcutaneous Electrical Nerve Stimulator Model: ST-304?

Transcutaneous Electrical Nerve Stimulator Model: ST-304 is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Shenzhen Future Electronic Co., Ltd.. The 510(k) number is K221092.

When did Transcutaneous Electrical Nerve Stimulator Model: ST-304 receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator Model: ST-304 received FDA 510(k) clearance on 2022-09-13, under 510(k) number K221092.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator Model: ST-304?

The FDA 510(k) record lists Shenzhen Future Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator Model: ST-304?

The FDA product code for Transcutaneous Electrical Nerve Stimulator Model: ST-304 is NUH.

其他以 Shenzhen Future Electronic 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：NUH）

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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