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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K030375
Device Name SOFT-TOUCH TENS ELECTRODE
Applicant
Pain Management Technologies
43 E. Market St.
Akron,  OH  44308
Applicant Contact JOSHUA LEFKOVITZ
Correspondent
Pain Management Technologies
43 E. Market St.
Akron,  OH  44308
Correspondent Contact JOSHUA LEFKOVITZ
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/04/2003
Decision Date 05/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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