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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K902226
Device Name MY-O-MATIC 5000I
Applicant
MONAD CORP.
908 E. HOLT AVE.
POMONA,  CA  91767
Applicant Contact MARK HANKINS
Correspondent
MONAD CORP.
908 E. HOLT AVE.
POMONA,  CA  91767
Correspondent Contact MARK HANKINS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/17/1990
Decision Date 06/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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