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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 K143198
Device Name Synapse Transcutaneous Electrical Stimulation Device
Applicant
Synapse Electroceutical Limited
1 Churchill Court, Hortons Way
Westerham,  GB TN16 1BT
Applicant Contact JOHN GILDERSLEEVE
Correspondent
MARTIN,BLANK & ASSOCIATES
3905 RHODE HARBOR RD
EDGEWATER,  MD  21037
Correspondent Contact MARY DADONE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/06/2014
Decision Date 05/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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