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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, Over-The-Counter
510(k) Number K133789
Device Name DOLPHIN NEUROSTIM OTC
Applicant
ACUMED MEDICAL LTD.
1151 HOPE STREET
STAMFORD,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
Compliance Consultants
1151 HOPE STREET
STAMFORD,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number882.5890
Classification Product Code
NUH  
Date Received12/12/2013
Decision Date 03/04/2015
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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