Cleared Traditional

K061645 - MAGPRO, MODEL R30

K061645 is an FDA 510(k) clearance for MAGPRO, manufactured by Tonica Elektronik A/S. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K061645 · Tonica Elektronik A/S · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2006
Decision
141d
Days
Class 2
Risk

K061645 is an FDA 510(k) clearance for the MAGPRO, MODEL R30. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on October 31, 2006 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 882.1870 - 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 - K061645

510(k) Number K061645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2006
Decision Date October 31, 2006
Days to Decision 141 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 149d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 107
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K061645.
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ORTHOMON
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K051864 · The Magstim Company , Ltd. · Dec 2005