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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K861896
Device Name UNI-TENS XL TENS
Applicant
Solcoor, Inc.
1655 N. Ft. Myer Dr. Suite 700
Arlington,  VA  22209
Applicant Contact BARBARA MARSDEN
Correspondent
Solcoor, Inc.
1655 N. Ft. Myer Dr. Suite 700
Arlington,  VA  22209
Correspondent Contact BARBARA MARSDEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/16/1986
Decision Date 09/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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