FDA 510(k)

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

Numéro K : K250286 · 2025-07-03

Date de décision2025-07-03

Code produitQPL

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant The Magstim Company Limited en tant que demandeur

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)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)

Dispositifs connexes (Code : QPL)

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

Source officielle

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