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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Other Uses
510(k) Number K000574
Device Name IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
Applicant
Wr Medical Electronics Co.
123 #2nd.St.
Stillwater,  MN  55082
Applicant Contact PATRICK J ANDERSON
Correspondent
Wr Medical Electronics Co.
123 #2nd.St.
Stillwater,  MN  55082
Correspondent Contact PATRICK J ANDERSON
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received02/22/2000
Decision Date 08/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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