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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 K192733
Device Name RelieforMe TENS/EMS Device Model UPK-GE01
Applicant
Umeheal , Ltd.
Floor 5, Bld F4, 1001 Zhongshanyuan Rd.
Tcl E City, Nanshan District
Shenzhen,  CN 518055
Applicant Contact Rui Lin
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Randy Jiang
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   NUH  
Date Received09/27/2019
Decision Date 12/23/2019
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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