Cleared Traditional

ViMove

K142494 · Dorsavi, Ltd. · Neurology
May 2015
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K142494 is an FDA 510(k) clearance for the ViMove, a Electromyograph, Diagnostic (Class II — Special Controls, product code IKN), submitted by Dorsavi, Ltd. (East Melbourne, AU). The FDA issued a Cleared decision on May 28, 2015, 265 days after receiving the submission on September 5, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K142494 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2014
Decision Date May 28, 2015
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IKN — Electromyograph, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1375