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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 K090717
Device Name FLEX-TENS
Applicant
Emsi
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact CHERITA JAMES
Correspondent
Emsi
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact CHERITA JAMES
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/18/2009
Decision Date 05/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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