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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K050847
Device Name IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
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 Number890.5850
Classification Product Code
IPF  
Date Received04/04/2005
Decision Date 06/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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