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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 K192264
Device Name HIVOX Spopad EMS SP-911, SP-921
Applicant
Hivox Biotek Inc.
5F., No. 123, Xinde Rd.
Sanchong Dist.
New Taipei City,  TW 24158
Applicant Contact Marx Lee
Correspondent
Hivox Biotek Inc.
5F., No. 123, Xinde Rd.
Sanchong Dist.
New Taipei City,  TW 24158
Correspondent Contact Marx Lee
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/21/2019
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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