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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 K014126
Device Name SANIDAD HEALTH-UP TENS MP-73725
Applicant
Roc Chinese-European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact JEN KE-MIN
Correspondent
Roc Chinese-European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact JEN KE-MIN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/17/2001
Decision Date 05/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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