Cleared Traditional

K162935 - Rapid2 Therapy System

K162935 is an FDA 510(k) clearance for Rapid2 Therapy System, manufactured by Magstim Company, Ltd.. The device is a Class 2 Neurology device with product code OBP cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K162935 · Magstim Company, Ltd. · Neurology device
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Mar 2017
Decision
141d
Days
Class 2
Risk

K162935 is an FDA 510(k) clearance for the Rapid2 Therapy System. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Magstim Company, Ltd. (Whitland, GB). The FDA issued a Cleared decision on March 10, 2017 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Magstim Company, Ltd. devices

FDA 510(k) Submission Details - K162935

510(k) Number K162935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2016
Decision Date March 10, 2017
Days to Decision 141 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 148d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBP Device Classification - Class 2, Special Controls

Product Code OBP Transcranial Magnetic Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.
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 Neurology devices follow this clearance model.