Cleared Traditional

K880464 - DYNATRON II

K880464 is the FDA 510(k) clearance for DYNATRON II by Dynatronics Laser Corp.. It is a Class 2 Neurology device (product code LBB) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K880464 · Dynatronics Laser Corp. · Neurology device
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Mar 1988
Decision
34d
Days
Class 2
Risk

K880464 is an FDA 510(k) clearance for the DYNATRON II. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Dynatronics Laser Corp. (Salt Lake City, US). The FDA issued a Cleared decision on March 8, 1988 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1240 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dynatronics Laser Corp. devices

Submission Details

510(k) Number K880464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1988
Decision Date March 08, 1988
Days to Decision 34 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 148d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBB Dynamometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1240
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.