Cleared Traditional

K250286 - Rapid2 Magnetic Stimulators (Magstim Rapid2

K250286 is an FDA 510(k) clearance for Rapid2 Magnetic Stimulators (Magstim Rapid2, manufactured by The Magstim Company Limited. The device is a Class 2 Physical Medicine device with product code QPL cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K250286 · The Magstim Company Limited · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
153d
Days
Class 2
Risk

K250286 is an FDA 510(k) clearance for the Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Su.... Classified as Electromagnetic Stimulator, Pain Relief (product code QPL), Class II - Special Controls.

Submitted by The Magstim Company Limited (Carmarthenshire, GB). The FDA issued a Cleared decision on July 3, 2025 after a review of 153 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all The Magstim Company Limited devices

FDA 510(k) Submission Details - K250286

510(k) Number K250286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPL Device Classification - Class 2, Special Controls

Product Code QPL Electromagnetic Stimulator, Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - QPL Electromagnetic Stimulator, Pain Relief

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