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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, for muscle conditioning
510(k) Number K143737
Device Name EM25 - glute toning device
Applicant
HIVOX BIOTEK, INC.
5 F., NO. 123, Shingde Road
San-chong District
New Taipei City,  TW 24158
Applicant Contact CLYTIE CHIOU
Correspondent
HIVOX BIOTEK, INC.
5 F., NO. 123, Shingde Road
San-chong District
New Taipei City,  TW 24158
Correspondent Contact CLYTIE CHIOU
Regulation Number890.5850
Classification Product Code
NGX  
Date Received12/30/2014
Decision Date 07/27/2015
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
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