Cleared Traditional

K961250 - DYNATRON 125 ULTRASOUND

K961250 is the FDA 510(k) clearance for DYNATRON 125 ULTRASOUND by Dynatronics Corp.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K961250 · Dynatronics Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
147d
Days
Class 2
Risk

K961250 is an FDA 510(k) clearance for the DYNATRON 125 ULTRASOUND. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on August 26, 1996 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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 K961250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date August 26, 1996
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 13
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K961250.
UltraTENS
K142976 · Shenzhen Dongdixin Technology Co., Ltd. · Aug 2015
FORTE, MODEL CPS ULTRASOUND
K982829 · Chattanooga Group, Inc. · Nov 1998
INTELECT LEGEND ULTRASOUND
K973024 · Chattanooga Group, Inc. · Nov 1997
INTELECT 222 P
K930307 · Chattanooga Group, Inc. · Jul 1993
INTELECT 205 PORTABLE ULTRASOUND UNIT
K841445 · Chattanooga Group, Inc. · May 1984
INTELECT 200 THERAPEUTIC ULTRASOUND
K841446 · Chattanooga Group, Inc. · May 1984