Cleared Traditional

K941577 - DYNATRON 550 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941577 · Dynatronics Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
519d
Days
Class 2
Risk

K941577 is an FDA 510(k) clearance for the DYNATRON 550. 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 1, 1995 after a review of 519 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Dynatronics Corp. devices

Submission Details

510(k) Number K941577 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 31, 1994
Decision Date September 01, 1995
Days to Decision 519 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
371d slower than avg
Panel avg: 148d · This submission: 519d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.