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)
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.

View all Dorsavi, Ltd. devices

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
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 148d · 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 Peers - IKN Electromyograph, Diagnostic

All 25
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