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FDA 510(k)

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)

K-Number: K250286 · 2025-07-03

ApplicantThe Magstim Company Limited
Decision Date2025-07-03
Product CodeQPL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by The Magstim Company Limited. The 510(k) number is K250286.

When was Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) approved by the FDA?

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

What company makes 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 manufactured by The Magstim Company Limited.

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.

Related Clinical Trials

NCT07568353 Brain Connectivity and Perceptive Surfaces in Chronic Low Back Pain (SUPER-RMNf) NOT_YET_RECRUITING

Other Devices by The Magstim Company Limited

K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)

Related Devices (Code: QPL)

K210021Axon TherapyNeuralace Medical, Inc. K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionTonica Elektronik A/S K233364Axon TherapyNeuralace Medical, Inc. K250309BTL-199BTL Industries, Inc. K241785StarFormer (M008-3T)Fotona D.O.O.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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