Who is the manufacturer of ViMove?

Dorsavi, Ltd. submitted the Traditional clearance for ViMove (K142494).

What is the FDA product code for ViMove?

IKN. It is classified under 21 CFR 890.1375 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for ViMove?

510(k) clearance (submission type: Traditional).

ViMove

K142494 · Dorsavi, Ltd. · IKN · May 28, 2015 · Physical Medicine

Device Facts

Record ID	K142494
Device Name	ViMove
Applicant	Dorsavi, Ltd.
Product Code	IKN · Physical Medicine
Decision Date	May 28, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.1375
Device Class	Class 2

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.