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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K060975
Device Name IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
Applicant
THERATECH, INC.
1109 MYATT BLVD.
MADISON,  TN  37115
Applicant Contact MICHAEL PRICE
Correspondent
THERATECH, INC.
1109 MYATT BLVD.
MADISON,  TN  37115
Correspondent Contact MICHAEL PRICE
Regulation Number882.5890
Classification Product Code
LIH  
Date Received04/10/2006
Decision Date 05/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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