ViMove

FDA 510(k) K142494 · Dorsavi, Ltd.

Substantially Equivalent

510(k) numberK142494

Submission

Device name
ViMove
Applicant
Dorsavi, Ltd.
East Melbourne, AU
Received
September 5, 2014
Decision date
May 28, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IKN – Electromyograph, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1375
Specialty
Physical Medicine

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Questions and answers

When was ViMove cleared by the FDA?

ViMove (K142494) received a 510(k) decision of Substantially Equivalent on May 28, 2015, 265 days after the submission was received.

What is the product code of K142494?

The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.