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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 K082514
Device Name TENS/EMS COMBO, EMS, TENS
Applicant
Medihightec Medical Co., Ltd.
4f, #180, Fu 1st St.,
Cidu District
Keelung City,  TW 20650
Applicant Contact MU-SHENG HUNG
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received09/02/2008
Decision Date 10/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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