Cleared Traditional

K961261 - DYNATRON 525

K961261 is an FDA 510(k) clearance for DYNATRON 525, manufactured by Dynatronics Corp.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K961261 · Dynatronics Corp. · Neurology device
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Sep 1996
Decision
156d
Days
Class 2
Risk

K961261 is an FDA 510(k) clearance for the DYNATRON 525. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 156 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dynatronics Corp. devices

FDA 510(k) Submission Details - K961261

510(k) Number K961261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1996
Decision Date September 05, 1996
Days to Decision 156 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 148d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 Neurology devices follow this clearance model.

Regulatory Peers - LIH Interferential Current Therapy

All 34
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K961261.
DYNATRON STS
K010565 · Dynatronics Corp. · May 2001
DYNATRON STS RX
K010948 · Dynatronics Corp. · May 2001
IF-727 INTERFERENTIAL STIMULATOR
K974585 · Skylark Device Co., Ltd. · Mar 1998
ISOTRON III, ISOTRON IV
K955387 · Excel Tech. , Ltd. · Mar 1996
MULTI III, IV
K955860 · Excel Tech. , Ltd. · Mar 1996
DYNATRON 650
K950348 · Dynatronics Corp. · Sep 1995