Cleared Special

K050847 - IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A

K050847 is an FDA 510(k) clearance for IF TRUE SINE INTERFERENTIAL STIMULATOR, manufactured by Theratech, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Special 510(k) pathway after a 74-day FDA review.

K050847 · Theratech, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
74d
Days
Class 2
Risk

K050847 is an FDA 510(k) clearance for the IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Theratech, Inc. (Madison, US). The FDA issued a Cleared decision on June 17, 2005 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 - K050847

510(k) Number K050847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2005
Decision Date June 17, 2005
Days to Decision 74 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 116d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 490
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K050847.
EASYSTIM NMS-28
K050921 · Easy Med Instrument Co., Ltd. · Dec 2005
AXIOM NVP8500
K051135 · Axiom Worldwide, Inc. · Aug 2005
AXIOM EPS8000
K050687 · Axiom Worldwide, Inc. · Jul 2005
FT2000 SEQUENCER FOR MUSCLE STIMULATOR
K050595 · Midwest Development · May 2005
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
K050046 · Compex Technologies, Inc. · Apr 2005
NEUROTECH KNEEHAB
K024258 · Bio-Medical Research, Ltd. · Mar 2005
K050847 · IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
Download PDF FDA Summary Theratech, Inc.