Cleared Traditional

K944935 - DYNATRON 250

K944935 is an FDA 510(k) clearance for DYNATRON 250, manufactured by Dynatronics Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K944935 · Dynatronics Corp. · Physical Medicine device
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Jun 1995
Decision
259d
Days
Class 2
Risk

K944935 is an FDA 510(k) clearance for the DYNATRON 250. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 259 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 - K944935

510(k) Number K944935 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 06, 1994
Decision Date June 22, 1995
Days to Decision 259 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 115d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 189
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K944935.
BX-400S
K942195 · Bloomex International, Inc. · Aug 1995
BX-200 SC
K943185 · Bloomex International, Inc. · Aug 1995
CHAL-2500
K946186 · Hogan & Hartson · Aug 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
GALVANIC GENERATOR MODEL IMF4150/A
K932916 · Biomedical Life Systems, Inc. · Jan 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992