免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Everyway 適用OTC TENS

K 號:K222488 · 2022-11-15

決定日期2022-11-15
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

Everyway Analog OTC TENS 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 2022-11-15 under 510(k) number K222488. 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 Everyway Analog OTC TENS?

Everyway Analog OTC TENS is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K222488.

When did Everyway Analog OTC TENS receive FDA 510(k) clearance?

Everyway Analog OTC TENS received FDA 510(k) clearance on 2022-11-15, under 510(k) number K222488.

Who is the listed applicant for Everyway Analog OTC TENS?

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 Everyway Analog OTC TENS?

The FDA product code for Everyway Analog OTC TENS is NUH.

相關臨床試驗

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。

其他以 Everyway Medical Instruments 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。

查看所有 13 項裝置 →

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑