FDA 510(k)

純淨衝擊

K 號：K251746 · 2025-07-02

決定日期2025-07-02

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Pure Impact is the device name listed in this FDA 510(k) record. The listed applicant is Sofwave Medical, Ltd.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K251746. 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 Pure Impact?

Pure Impact is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Sofwave Medical, Ltd.. The 510(k) number is K251746.

When did Pure Impact receive FDA 510(k) clearance?

Pure Impact received FDA 510(k) clearance on 2025-07-02, under 510(k) number K251746.

Who is the listed applicant for Pure Impact?

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

What is the FDA product code for Pure Impact?

The FDA product code for Pure Impact is NGX.

其他以 Sofwave Medical, 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。

K250146SofWave系統 K241685SofWave系統 K240687SofWave系統 K233104SofWave系統 K232455SofWave系統 K231537SofWave系統

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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。

K253790高強度聚焦電磁刺激器（FE60）Beijing Winkonlaser Technology Limited K253926迪阿科爾ShenB Co., Ltd.K253636Zionic Pro Max (電動肌肉刺激器)Termosalud S.L.K253408涼頻Zimmer Medizinsysteme GmbH K252154攜帶式電刺激治療設備（LGT-2320BE、LGT-2320ME 及 LGT-2320SP）Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ 腰部肌肉刺激器 (OT01-1003)Motive Health, Inc.

官方來源

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