Cleared Special

K060975 - IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2

K060975 is an FDA 510(k) clearance for IF TRUE SINE INTERFERENTIAL STIMULATOR ..., manufactured by Theratech, Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Special 510(k) pathway after a 30-day FDA review.

K060975 · Theratech, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K060975

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LIH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LIH Interferential Current Therapy

All 71
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K060975.
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K092763 · Well-Life Healthcare Limited · Oct 2009
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
K090023 · Well-Life Healthcare Limited · Jan 2009
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
K070890 · Everlife Medical Equipment Co., Ltd. · Jun 2007
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
K052289 · Biowave Corporation · Dec 2005
INF 4160, MODEL D-FJ27F
K043407 · Fuji Dynamics Limited · Feb 2005
INFINITY ELECTROTHERAPY SYSTEM
K042057 · Empi · Dec 2004
K060975 · IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
Download PDF FDA Summary Theratech, Inc.