Cleared Traditional

K202490 - Avid CT2

K202490 is the FDA 510(k) clearance for Avid CT2 by Vision Quest Industries Inc./Dba VQ Orthocare. It is a Class 2 Neurology device (product code IPF) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K202490 · Vision Quest Industries Inc./Dba VQ Orthocare · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
77d
Days
Class 2
Risk

K202490 is an FDA 510(k) clearance for the Avid CT2. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Vision Quest Industries Inc./Dba VQ Orthocare (Vista, US). The FDA issued a Cleared decision on November 16, 2020 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5850 - 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 Vision Quest Industries Inc./Dba VQ Orthocare devices

Submission Details

510(k) Number K202490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2020
Decision Date November 16, 2020
Days to Decision 77 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
71d faster than avg
Panel avg: 148d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 114
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K202490.
emField
K203488 · Zimmer Medizinsysteme GmbH · Feb 2021
Biofeedback Nerve and Muscle Stimulator
K202648 · Shenzhen Konmed Technology Co., Ltd. · Dec 2020
Physiq
K202079 · El.En Electronic Engineering Spa · Nov 2020
g.Estim FES
K200088 · G.Tec Medical Engineering GmbH · Oct 2020
Medline DeNovo 4Pro Electrical Stimulation Device
K201290 · Medline Industries, Inc. · Sep 2020
ETD Family of Electrotherapy Devices
K201958 · Therasigma, LLC · Aug 2020