Je 2000

FDA 510(k) K993878 · Jack'S Electrodes

Substantially Equivalent

510(k) numberK993878

Submission

Device name
Je 2000
Applicant
Jack'S Electrodes
Altadena, CA, US
Received
November 15, 1999
Decision date
February 1, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code IKN

510(k)DeviceApplicantDecision
K172743Natus VikingQuestIKN · Special Natus Neurology Incorporated12/19/2017SE
K163150ViMove2IKN · Special Dorsavi, Ltd.07/14/2017SE
K162383Cadwell Sierra Summit, Cadwell Sierra AscentIKN · Traditional Cadwell Industries, Inc.03/01/2017SE
K142494ViMoveIKN · Traditional Dorsavi, Ltd.05/28/2015SE
K131094VimoveIKN · Traditional Dorsa VI Pty., Ltd.07/11/2014SE
K123902Physical Monitoring Registration Unit-S (Pmru-S)IKN · Traditional Oktx, LLC09/13/2013SE
K123399Myovision 3.0 Wirefree SystemIKN · Traditional Precision Biometrics, Inc.08/01/2013SE
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

More from Spinematrix, Inc.

510(k)DeviceDecision
K974119Disposable Needle Electrode (Alm), Disposable Needle Electrode (DLM)GXZ · Traditional 01/28/1998SE

Questions and answers

When was Je 2000 cleared by the FDA?

Je 2000 (K993878) received a 510(k) decision of Substantially Equivalent on February 1, 2000, 78 days after the submission was received.

What is the product code of K993878?

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