FDA 510(k)

Rapid2 靜磁刺激器（Magstim Rapid2、Magstim Super Rapid2、Magstim Super Rapid2 Plus1）

K 號：K250286 · 2025-07-03

決定日期2025-07-03

產品代碼QPL

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) is the device name listed in this FDA 510(k) record. The listed applicant is The Magstim Company Limited. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K250286. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)?

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is The Magstim Company Limited. The 510(k) number is K250286.

When did Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) receive FDA 510(k) clearance?

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250286.

Who is the listed applicant for Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)?

The FDA 510(k) record lists The Magstim Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)?

The FDA product code for Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) is QPL.

其他以 The Magstim Company Limited 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。

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相關器械（代碼：QPL）

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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