Vimove

FDA 510(k) K131094 · Dorsa VI Pty., Ltd.

Substantially Equivalent

510(k) numberK131094

Submission

Device name
Vimove
Applicant
Dorsa VI Pty., Ltd.
Chalotte, NC, US
Received
April 18, 2013
Decision date
July 11, 2014
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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K123902Physical Monitoring Registration Unit-S (Pmru-S)IKN · Traditional Oktx, LLC09/13/2013SE
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K113074Cmap ProIKN · Traditional Medical Technologies, Inc.02/02/2012SE
K102610Focus Emg DeviceIKN · Traditional Teleemg, LLC USA03/04/2011SE
K110048Cersr Electromyography SystemIKN · Special Spinematrix, Inc.01/26/2011SE
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Questions and answers

When was Vimove cleared by the FDA?

Vimove (K131094) received a 510(k) decision of Substantially Equivalent on July 11, 2014, 449 days after the submission was received.

What is the product code of K131094?

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