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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 K183074
Device Name TENS and EMS Stimulator, TENS Stimulator
Applicant
Astek Technology , Ltd.
# 118 Taizih Rd., Rende Dist
Tainan City,  TW 71741
Applicant Contact You-Jhe Lin
Correspondent
Astek Technology , Ltd.
# 118 Taizih Rd., Rende Dist
Tainan City,  TW 71741
Correspondent Contact You-Jhe Lin
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received11/05/2018
Decision Date 01/11/2020
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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