Cleared Traditional

VIMOVE

K131094 · Dorsa VI Pty., Ltd. · Neurology

Jul 2014

Decision

449d

Days

Class 2

Risk

About This 510(k) Submission

K131094 is an FDA 510(k) clearance for the VIMOVE, a Electromyograph, Diagnostic (Class II — Special Controls, product code IKN), submitted by Dorsa VI Pty., Ltd. (Chalotte, US). The FDA issued a Cleared decision on July 11, 2014, 449 days after receiving the submission on April 18, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number	K131094 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2013
Decision Date	July 11, 2014
Days to Decision	449 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF