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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 K153224
Device Name VitalStim(R) Plus Electrotherapy System
Applicant
DJO, LLC
1430 DECISION STREET
vista,  CA  92081
Applicant Contact natalia shirina
Correspondent
DJO, LLC
1430 DECISION STREET
vista,  CA  92081
Correspondent Contact natalia shirina
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
HCC  
Date Received11/06/2015
Decision Date 02/17/2016
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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