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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K931401
Device Name EMS
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 Number890.5850
Classification Product Code
IPF  
Date Received03/19/1993
Decision Date 03/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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