Cleared Special

IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 (K060975) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060975 · Theratech, Inc. · Neurology device
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May 2006
Decision
30d
Days
Class 2
Risk

K060975 is an FDA 510(k) clearance for the IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Theratech, Inc. (Madison, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 Theratech, Inc. devices

Submission Details

510(k) Number K060975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date May 10, 2006
Days to Decision 30 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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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.