Cleared Traditional

OMNIVAC (VACUUM ELECTRODE SYSTEM) (K861039) - FDA 510(k) Clearance

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

K861039 · Physio Technology, Inc. · Neurology device
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Sep 1986
Decision
192d
Days
Class 2
Risk

K861039 is an FDA 510(k) clearance for the OMNIVAC (VACUUM ELECTRODE SYSTEM). Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Physio Technology, Inc. (Topeka, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 192 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 Physio Technology, Inc. devices

Submission Details

510(k) Number K861039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date September 26, 1986
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 148d · This submission: 192d
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.