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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 K060368
Device Name INSPIRSTAR IS02 MICROCURRENT STIMULATOR
Applicant
Inspirstar, Inc.
891 N. Naples Dr.
Chandler,  AZ  85226
Applicant Contact NING WU
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/13/2006
Decision Date 03/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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