FDA 510(k)

Li電池驅動OTC TENS/EMS，型號EM-6000、EM-6100、EM-6200及EM-6300

K 號：K202470 · 2020-11-25

決定日期2020-11-25

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

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K202470. 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 Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300?

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K202470.

When did Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 receive FDA 510(k) clearance?

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202470.

Who is the listed applicant for Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300?

The FDA product code for Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 is NUH.

其他以 Everyway Medical Instruments Co.,Ltd 為申請人之記錄

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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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官方來源

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