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

FDA 510(k) K250286 · The Magstim Company Limited

Substantially Equivalent

510(k) numberK250286

Submission

Device name
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
Applicant
The Magstim Company Limited
Carmarthenshire, GB
Received
January 31, 2025
Decision date
July 3, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QPL – Electromagnetic Stimulator, Pain Relief
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

Intended to apply a magnetic-field induced electrical current to treat pain.

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Questions and answers

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

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) (K250286) received a 510(k) decision of Substantially Equivalent on July 3, 2025, 153 days after the submission was received.

What is the product code of K250286?

The FDA product code is QPL – Electromagnetic Stimulator, Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.