Cleared Traditional

K051680 - DYNATRON DX2 TRACTION UNIT

K051680 is the FDA 510(k) clearance for DYNATRON DX2 TRACTION UNIT by Dynatronics Corp.. It is a Class 2 Physical Medicine device (product code ILY) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K051680 · Dynatronics Corp. · Physical Medicine device
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Oct 2005
Decision
110d
Days
Class 2
Risk

K051680 is an FDA 510(k) clearance for the DYNATRON DX2 TRACTION UNIT. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on October 11, 2005 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Dynatronics Corp. devices

Submission Details

510(k) Number K051680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2005
Decision Date October 11, 2005
Days to Decision 110 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 115d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 - ILY Lamp, Infrared, Therapeutic Heating

All 13
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