Cleared Traditional

K900639 - DYNATRON 350 EMG/BIOFEEDBACK ANALYZER

K900639 is an FDA 510(k) clearance for DYNATRON 350 EMG/BIOFEEDBACK ANALYZER, manufactured by Dynatronics Laser Corp.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K900639 · Dynatronics Laser Corp. · Neurology device
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Oct 1990
Decision
237d
Days
Class 2
Risk

K900639 is an FDA 510(k) clearance for the DYNATRON 350 EMG/BIOFEEDBACK ANALYZER. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Dynatronics Laser Corp. (Salt Lake City, US). The FDA issued a Cleared decision on October 4, 1990 after a review of 237 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Laser Corp. devices

FDA 510(k) Submission Details - K900639

510(k) Number K900639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1990
Decision Date October 04, 1990
Days to Decision 237 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 148d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 57
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K900639.
MYOTRAC+/S, MYODAC+/S
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MYODAC
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MYOTRAC
K881416 · Thought Technology , Ltd. · Sep 1988