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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 K884833
Device Name ULTRA 2000 (T.E.N.S.)
Applicant
Maxima Intl., Inc.
P.O. Box 526944
Miami,  FL  33152
Applicant Contact ED MOLINA
Correspondent
Maxima Intl., Inc.
P.O. Box 526944
Miami,  FL  33152
Correspondent Contact ED MOLINA
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/18/1988
Decision Date 02/13/1989
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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