Cleared Traditional

K870947 - DYNATRON 500

K870947 is an FDA 510(k) clearance for DYNATRON 500, 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 162-day FDA review.

K870947 · Dynatronics Corp. · Physical Medicine device
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Aug 1987
Decision
162d
Days
Class 2
Risk

K870947 is an FDA 510(k) clearance for the DYNATRON 500. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Dynatronics Corp. (Washington, US). The FDA issued a Cleared decision on August 18, 1987 after a review of 162 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 - K870947

510(k) Number K870947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1987
Decision Date August 18, 1987
Days to Decision 162 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
47d slower than avg
Panel avg: 115d · This submission: 162d
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 K870947.
INTELECT 775
K872655 · Chattanooga Group, Inc. · Nov 1987
MYOSTIM(TM), MODEL 6600
K872753 · Medical Devices, Inc. · Oct 1987
INTELECT MODEL 575
K872654 · Chattanooga Group, Inc. · Sep 1987
DYNATRON 438
K870515 · Henley Intl. · Jun 1987
MYOPAC (TM), MODEL 9600
K864625 · Medical Devices, Inc. · Dec 1986
EMPI MODEL 712, LOGIX(TM), NMS
K864010 · Empi · Dec 1986