Cleared Traditional

K183692 - Avid IF2

K183692 is the FDA 510(k) clearance for Avid IF2 by Vision Quest Industries Inc./Dba VQ Orthocare. It is a Class 2 Neurology device (product code LIH) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K183692 · Vision Quest Industries Inc./Dba VQ Orthocare · Neurology device
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Jun 2019
Decision
163d
Days
Class 2
Risk

K183692 is an FDA 510(k) clearance for the Avid IF2. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Vision Quest Industries Inc./Dba VQ Orthocare (Vista, US). The FDA issued a Cleared decision on June 12, 2019 after a review of 163 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 Vision Quest Industries Inc./Dba VQ Orthocare devices

Submission Details

510(k) Number K183692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2018
Decision Date June 12, 2019
Days to Decision 163 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 148d · This submission: 163d
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.

Regulatory Peers - LIH Interferential Current Therapy

All 12
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