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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 K062284
Device Name CES ULTRA
Applicant
NEURO-FITNESS LLC
P.O. BOX 1031
SNOQUALMIE,  WA  98065
Applicant Contact MICHAEL STEVENS
Correspondent
NEURO-FITNESS LLC
P.O. BOX 1031
SNOQUALMIE,  WA  98065
Correspondent Contact MICHAEL STEVENS
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received08/07/2006
Decision Date 04/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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