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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K160246
Device Name SimulCare II(TM)
Applicant
Xanacare Technologies, LLC
9185 E. Kenyon Ave.
# 270
Denver,  CO  80237
Applicant Contact THOMAS C SIIROLA
Correspondent
Hart Consulting, LLC
2964 Redhaven Way
Littleton,  CO  80126
Correspondent Contact Charles M.(Mike) Hart
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
ILY   ISA  
Date Received02/01/2016
Decision Date 10/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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