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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, over-the-counter
510(k) Number K062532
Device Name ELECTROPULSE - LOW BACK PAIN
Applicant
PAIN RELIEF TECHNOLOGIES
15048 SW CAPSTONE CT.
BEAVERTON,  OR  97007
Applicant Contact KENDALL GORHAM
Correspondent
PAIN RELIEF TECHNOLOGIES
15048 SW CAPSTONE CT.
BEAVERTON,  OR  97007
Correspondent Contact KENDALL GORHAM
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
ILY   IRO  
Date Received08/28/2006
Decision Date 02/09/2007
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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