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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 K896787
Device Name TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
Applicant
Saratoga Intl., Inc.
828 Charcot Ave.
San Jose,  CA  95131
Applicant Contact MIKE CHUANG
Correspondent
Saratoga Intl., Inc.
828 Charcot Ave.
San Jose,  CA  95131
Correspondent Contact MIKE CHUANG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/04/1989
Decision Date 07/30/1990
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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