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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, Specific Uses
510(k) Number K954126
Device Name TRANSQ ELECTRODE PHORESOR II
Applicant
Iomed, Inc.
1290 W. 2320 S., Suite A
Salt Lake City,  UT  84119
Applicant Contact ANNE T CARTER
Correspondent
Iomed, Inc.
1290 W. 2320 S., Suite A
Salt Lake City,  UT  84119
Correspondent Contact ANNE T CARTER
Regulation Number890.5525
Classification Product Code
KTB  
Date Received09/01/1995
Decision Date 01/19/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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