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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 S.W. HEATHER LN.
BEAVERTON,  OR  97008 -6011
Applicant Contact THOMAS H CHARTERS
Correspondent
TH CHARTERS, INC.
9985 S.W. HEATHER LN.
BEAVERTON,  OR  97008 -6011
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
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