Cleared Traditional

Avid IF2

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

About This 510(k) Submission

K183692 is an FDA 510(k) clearance for the Avid IF2, a Interferential Current Therapy (Class II — Special Controls, product code LIH), submitted by Vision Quest Industries Inc./Dba VQ Orthocare (Vista, US). The FDA issued a Cleared decision on June 12, 2019, 163 days after receiving the submission on December 31, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K183692 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LIH — Interferential Current Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890