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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K070412
Device Name ELEXOMA MEDIC
Applicant
Redplane AG
Baarerstrasse 8
Zug,  CH 6300
Applicant Contact JAEN LABUSCHAGNE
Correspondent
Redplane AG
Baarerstrasse 8
Zug,  CH 6300
Correspondent Contact JAEN LABUSCHAGNE
Regulation Number882.5800
Classification Product Code
QJQ  
Subsequent Product Code
GZJ  
Date Received02/12/2007
Decision Date 05/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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