Cleared Traditional

K132057 - DYNATRON PELTIER THERMOSTIM PROBE

K132057 is the FDA 510(k) clearance for DYNATRON PELTIER THERMOSTIM PROBE by Dynatronics Corp.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K132057 · Dynatronics Corp. · Neurology device
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Jan 2014
Decision
205d
Days
Class 2
Risk

K132057 is an FDA 510(k) clearance for the DYNATRON PELTIER THERMOSTIM PROBE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on January 24, 2014 after a review of 205 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 Dynatronics Corp. devices

Submission Details

510(k) Number K132057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2013
Decision Date January 24, 2014
Days to Decision 205 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
57d slower than avg
Panel avg: 148d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 107
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