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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 K862355
Device Name TRANS-PULSE MODEL #1103
Applicant
The Sun Co.
8124 Brooks St.
Tampa,  FL  33604
Applicant Contact RODNEY E DANLEY
Correspondent
The Sun Co.
8124 Brooks St.
Tampa,  FL  33604
Correspondent Contact RODNEY E DANLEY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/23/1986
Decision Date 08/19/1986
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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