Cleared Traditional

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

K250286 · The Magstim Company Limited · Physical Medicine
Jul 2025
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K250286 is an FDA 510(k) clearance for the Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1), a Electromagnetic Stimulator, Pain Relief (Class II — Special Controls, product code QPL), submitted by The Magstim Company Limited (Carmarthenshire, GB). The FDA issued a Cleared decision on July 3, 2025, 153 days after receiving the submission on January 31, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K250286 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2025
Decision Date July 03, 2025
Days to Decision 153 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code QPL — Electromagnetic Stimulator, Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890
Definition Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.