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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 K060846
Device Name THERAPEUTIC MASSAGE COMPANION
Applicant
Endurance Therapeutics
122b - First St. NE
Dauphin, Manitoba,  CA R7N 1B5
Applicant Contact BRAD BREZDEN
Correspondent
Endurance Therapeutics
122b - First St. NE
Dauphin, Manitoba,  CA R7N 1B5
Correspondent Contact BRAD BREZDEN
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received03/28/2006
Decision Date 12/03/2007
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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