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)

Zionic Pro Max (電波頻率)

K 號:K243716 · 2025-05-28

決定日期2025-05-28
產品代碼PBX
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Zionic Pro Max (Radiofrequency) is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud S.L.. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K243716. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zionic Pro Max (Radiofrequency)?

Zionic Pro Max (Radiofrequency) is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Termosalud S.L.. The 510(k) number is K243716.

When did Zionic Pro Max (Radiofrequency) receive FDA 510(k) clearance?

Zionic Pro Max (Radiofrequency) received FDA 510(k) clearance on 2025-05-28, under 510(k) number K243716.

Who is the listed applicant for Zionic Pro Max (Radiofrequency)?

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

What is the FDA product code for Zionic Pro Max (Radiofrequency)?

The FDA product code for Zionic Pro Max (Radiofrequency) is PBX.

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 Termosalud S.L. 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。

相關器械(代碼:PBX)

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。

↑