Cleared Traditional

K141342 - WEARABLE THERAPY GARMENTS

K141342 is an FDA 510(k) clearance for WEARABLE THERAPY GARMENTS, manufactured by Axiobionics, LLC. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K141342 · Axiobionics, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
177d
Days
Class 2
Risk

K141342 is an FDA 510(k) clearance for the WEARABLE THERAPY GARMENTS. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Axiobionics, LLC (South Lyon, US). The FDA issued a Cleared decision on November 14, 2014 after a review of 177 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 Axiobionics, LLC devices

FDA 510(k) Submission Details - K141342

510(k) Number K141342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date November 14, 2014
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 148d · This submission: 177d
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 221
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K141342.
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
K143506 · Covidien · Apr 2015
ASCEND ELECTRODE
K140586 · Neurometrix, Inc. · Nov 2014
GARMENT ELECTRODES
K141076 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2014
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K131720 · Hivox Biotek, Inc. · Jul 2014
DYNATRON PELTIER THERMOSTIM PROBE
K132057 · Dynatronics Corp. · Jan 2014
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
K130287 · Rhythmlink International, LLC · May 2013