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FDA 510(k)

Gnesis EMS Plus

K 號：K230261 · 2023-06-06

申請人Creative Fitness Developments S.L.
決定日期2023-06-06
產品代碼NGX
諮詢委員會PM
決定相當於

器材摘要

Gnesis EMS Plus is the device name listed in this FDA 510(k) record. The listed applicant is Creative Fitness Developments S.L.. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K230261. 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 Gnesis EMS Plus?

Gnesis EMS Plus is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Creative Fitness Developments S.L.. The 510(k) number is K230261.

When did Gnesis EMS Plus receive FDA 510(k) clearance?

Gnesis EMS Plus received FDA 510(k) clearance on 2023-06-06, under 510(k) number K230261.

Who is the listed applicant for Gnesis EMS Plus?

The FDA 510(k) record lists Creative Fitness Developments S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gnesis EMS Plus?

The FDA product code for Gnesis EMS Plus is NGX.

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。

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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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