Cleared Traditional

K083441 - FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION

K083441 is an FDA 510(k) clearance for FREEDOM STIM 100 AND 200 ELECTRODE AND ..., manufactured by Motion Medical Products, LLC. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K083441 · Motion Medical Products, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
183d
Days
Class 2
Risk

K083441 is an FDA 510(k) clearance for the FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Motion Medical Products, LLC (Vista, US). The FDA issued a Cleared decision on May 22, 2009 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Motion Medical Products, LLC devices

FDA 510(k) Submission Details - K083441

510(k) Number K083441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2008
Decision Date May 22, 2009
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 243
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K083441.
BIS QUATRO SENSOR
K093183 · Aspect Medical Systems, Inc. · Oct 2009
LIFECARE ELECTRODES
K083302 · Everyway Medical Instruments Co.,Ltd · Aug 2009
BIS CLICK SENSOR/CABLE
K091854 · Aspect Medical Systems, Inc. · Jul 2009
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
K082065 · Well-Life Healthcare Limited · Apr 2009
UNIVERSAL ELECTRODES
K083818 · Neurometrix, Inc. · Jan 2009
GE ENTROPY SENSOR
K082540 · Ge Healthcare · Nov 2008