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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 K861501
Device Name EXER-STIM 2
Applicant
Th Charters, Inc.
9985 SW Heather Ln.
Beaverton,  OR  97008
Applicant Contact THOMAS H CHARTERS
Correspondent
Th Charters, Inc.
9985 SW Heather Ln.
Beaverton,  OR  97008
Correspondent Contact THOMAS H CHARTERS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/23/1986
Decision Date 05/08/1986
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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