Cleared Traditional

K961250 - DYNATRON 125 ULTRASOUND

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

K961250 · Dynatronics Corp. · Physical Medicine device
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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

FDA 510(k) Submission Details - K961250

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
Combination Product No
PCCP Authorized No
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.

IMI Device Classification - Class 2, Special Controls

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 49
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K961250.
FORTE, MODEL CPS ULTRASOUND
K982829 · Chattanooga Group, Inc. · Nov 1998
INTELECT LEGEND ULTRASOUND
K973024 · Chattanooga Group, Inc. · Nov 1997
ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
K970131 · C.L. Mcintosh & Assoc., Inc. · Jun 1997
RICH-MAR US-II ULTRASOUND
K950564 · Rich-Mar Corp. · May 1995
INTELECT 222 P
K930307 · Chattanooga Group, Inc. · Jul 1993
SONOPULS 590
K920983 · Henley Intl. · Mar 1993