Cleared Traditional

K170114 - MagVita TMS Therapy - w/MagPro R20

K170114 is an FDA 510(k) clearance for MagVita TMS Therapy - w/MagPro R20, manufactured by Tonica Elektronik A/S. The device is a Class 2 Neurology device with product code OBP cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K170114 · Tonica Elektronik A/S · Neurology device
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May 2017
Decision
109d
Days
Class 2
Risk

K170114 is an FDA 510(k) clearance for the MagVita TMS Therapy - w/MagPro R20. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on May 1, 2017 after a review of 109 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 Tonica Elektronik A/S devices

FDA 510(k) Submission Details - K170114

510(k) Number K170114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2017
Decision Date May 01, 2017
Days to Decision 109 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
39d faster than avg
Panel avg: 148d · This submission: 109d
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.