Cleared Special

K163150 - ViMove2

K163150 is an FDA 510(k) clearance for ViMove2, manufactured by Dorsavi, Ltd.. The device is a Class 2 Neurology device with product code IKN cleared through the Special 510(k) pathway after a 247-day FDA review.

K163150 · Dorsavi, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
247d
Days
Class 2
Risk

K163150 is an FDA 510(k) clearance for the ViMove2. 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 July 14, 2017 after a review of 247 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K163150

510(k) Number K163150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2016
Decision Date July 14, 2017
Days to Decision 247 days
Submission Type Special
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
98d slower than avg
Panel avg: 149d · This submission: 247d
Pathway characteristics
Modification to existing cleared device.

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

Pushmed, LLC
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 K163150.
Natus VikingQuest
K172743 · Natus Neurology Incorporated · Dec 2017
Cadwell Sierra Summit, Cadwell Sierra Ascent
K162383 · Cadwell Industries, Inc. · Mar 2017
ViMove
K142494 · Dorsavi, Ltd. · May 2015
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
K163150 · ViMove2
Download PDF FDA Summary Dorsavi, Ltd.