Cleared Traditional

K870515 - DYNATRON 438

K870515 is the FDA 510(k) clearance for DYNATRON 438 by Henley Intl.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K870515 · Henley Intl. · Physical Medicine device
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Jun 1987
Decision
131d
Days
Class 2
Risk

K870515 is an FDA 510(k) clearance for the DYNATRON 438. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Henley Intl. (Houston, US). The FDA issued a Cleared decision on June 16, 1987 after a review of 131 days - within the typical 510(k) review window.

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 Henley Intl. devices

Submission Details

510(k) Number K870515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1987
Decision Date June 16, 1987
Days to Decision 131 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
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 134
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K870515.
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
MYOPAC (TM), MODEL 9600
K864625 · Medical Devices, Inc. · Dec 1986
EMPI MODEL 712, LOGIX(TM), NMS
K864010 · Empi · Dec 1986
INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986