Cleared Traditional

K142494 - ViMove

K142494 is an FDA 510(k) clearance for ViMove, manufactured by Dorsavi, Ltd.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K142494 · Dorsavi, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
265d
Days
Class 2
Risk

K142494 is an FDA 510(k) clearance for the ViMove. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Dorsavi, Ltd. (East Melbourne, AU). The FDA issued a Cleared decision on May 28, 2015 after a review of 265 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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.

FDA 510(k) Submission Details - K142494

510(k) Number K142494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 149d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 Consultant

Mjrac
Bosmat Friedman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IKN Electromyograph, Diagnostic

All 57
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K142494.
Natus VikingQuest
K172743 · Natus Neurology Incorporated · Dec 2017
ViMove2
K163150 · Dorsavi, Ltd. · Jul 2017
Cadwell Sierra Summit, Cadwell Sierra Ascent
K162383 · Cadwell Industries, Inc. · Mar 2017
VIMOVE
K131094 · Dorsa VI Pty., Ltd. · Jul 2014
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
K123902 · Oktx, LLC · Sep 2013
MYOVISION 3.0 WIREFREE SYSTEM
K123399 · Precision Biometrics, Inc. · Aug 2013
K142494 · ViMove
Download PDF FDA Summary Dorsavi, Ltd.