Cleared Traditional

K920939 - DYNATRON 300 ULRASOUND

K920939 is an FDA 510(k) clearance for DYNATRON 300 ULRASOUND, manufactured by Dynatronics Laser Corp.. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K920939 · Dynatronics Laser Corp. · Physical Medicine device
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Mar 1993
Decision
371d
Days
Class 2
Risk

K920939 is an FDA 510(k) clearance for the DYNATRON 300 ULRASOUND. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Dynatronics Laser Corp. (Salt Lake City, US). The FDA issued a Cleared decision on March 4, 1993 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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. Elevated predicate reliance profile. 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 Laser Corp. devices

FDA 510(k) Submission Details - K920939

510(k) Number K920939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date March 04, 1993
Days to Decision 371 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 115d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMG Device Classification - Class 2, Special Controls

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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 - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 44
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K920939.
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