FDA 510(k)

Aura Wave

K 號：K250896 · 2025-12-02

決定日期2025-12-02

產品代碼SGT

諮詢委員會PM

決定相當於

器材摘要

Aura Wave is the device name listed in this FDA 510(k) record. The listed applicant is Aura Wellness, LLC. It received FDA 510(k) clearance on 2025-12-02 under 510(k) number K250896. The device is classified under product code SGT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aura Wave?

Aura Wave is a medical device that received FDA 510(k) clearance on 2025-12-02. The listed applicant is Aura Wellness, LLC. The 510(k) number is K250896.

When did Aura Wave receive FDA 510(k) clearance?

Aura Wave received FDA 510(k) clearance on 2025-12-02, under 510(k) number K250896.

Who is the listed applicant for Aura Wave?

FDA 510(k) 記錄將 Aura Wellness, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aura Wave?

The FDA product code for Aura Wave is SGT.

其他以 Aura Wellness, LLC 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。

K262788諾瓦HD+K220938諾瓦HD+

相關器械（代碼：SGT）

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。

K262788諾瓦HD+Aura Wellness, LLC

官方來源

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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。