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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 K031310
Device Name TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR
Applicant
Tai Sheng Electrical Machinery Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact JEN KE-MIN
Correspondent
Tai Sheng Electrical Machinery Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact JEN KE-MIN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/24/2003
Decision Date 04/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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