FDA 510(k)

電磁刺激器設備（型號 EM Contouring 和 Tesla Duet）

K 號：K231318 · 2023-07-07

決定日期2023-07-07

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K231318. 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 Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)?

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K231318.

When did Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) receive FDA 510(k) clearance?

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) received FDA 510(k) clearance on 2023-07-07, under 510(k) number K231318.

Who is the listed applicant for Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)?

The FDA 510(k) record lists Beijing Adss Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)?

The FDA product code for Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) is NGX.

其他以 Beijing Adss Development Co., Ltd. 為申請人之記錄

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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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