FDA 510(k)

Rapid2 磁刺激器（Magstim Rapid2，Magstim Super Rapid2，Magstim Super Rapid2 Plus1）

K号: K250286 · 2025-07-03

决定日期2025-07-03

产品代码QPL

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决定实质等同

器械摘要

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.

常见问题

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.

列明The Magstim Company Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243869Horizon® 3.0 TMS 疗法系统 (Horizon 3.0 Inspire)；Horizon® 3.0 TMS 疗法系统 (Horizon 3.0 with StimGuide Pro)；Horizon® 3.0 TMS 疗法系统 (Horizon 3.0)K241518Horizon® 3.0 TMS 疗法系统 (Horizon 3.0 Inspire)；Horizon® 3.0 TMS 疗法系统 (Horizon 3.0 with StimGuide Pro)；Horizon® 3.0 TMS 疗法系统 (Horizon 3.0)

官方来源

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