Cleared Special

K071821 - COILS

K071821 is an FDA 510(k) clearance for COILS, manufactured by Tonica Elektronik A/S. The device is a Class 2 Neurology device with product code GWF cleared through the Special 510(k) pathway after a 24-day FDA review.

K071821 · Tonica Elektronik A/S · Neurology device
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Jul 2007
Decision
24d
Days
Class 2
Risk

K071821 is an FDA 510(k) clearance for the COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65. 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 July 27, 2007 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tonica Elektronik A/S devices

FDA 510(k) Submission Details - K071821

510(k) Number K071821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2007
Decision Date July 27, 2007
Days to Decision 24 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 148d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 61
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K071821.
NIM 3.0
K083124 · Medtronic Xomed, Inc. · Feb 2009
SEN-4100 ELECTRIC STIMULATOR
K071969 · Nihon Kohden America, Inc. · Oct 2008
NEUROVISION JJB SYSTEM
K072343 · Nuvasive, Inc. · Oct 2007
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
K062765 · Nuvasive, Inc. · Jan 2007
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc. · Aug 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · Nuvasive, Inc. · Jul 2005