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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 K051128
Device Name ELECTROPULSE
Applicant
PAIN RELIEF TECHNOLOGIES
15440 N. 71ST STREET #215
SCOTTSDALE,  AZ  85254
Applicant Contact KENDALL GORHAM
Correspondent
PAIN RELIEF TECHNOLOGIES
15440 N. 71ST STREET #215
SCOTTSDALE,  AZ  85254
Correspondent Contact KENDALL GORHAM
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
ILY   IRO  
Date Received05/03/2005
Decision Date 03/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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