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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 K071093
Device Name SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202
Applicant
San Shih Electrical Enterprise Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Applicant Contact Ke-Min Jen
Correspondent
San Shih Electrical Enterprise Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/18/2007
Decision Date 12/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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