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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K170391
Device Name ANSiStim-PP
Applicant
Dyansys, Inc.
300, N. Bayshore Blvd.
San Mateo,  CA  94401
Applicant Contact Srini Nageshwar
Correspondent
Dyansys, Inc.
300, N. Bayshore Blvd.
San Mateo,  CA  94401
Correspondent Contact Srini Nageshwar
Classification Product Code
BWK  
Date Received02/08/2017
Decision Date 03/09/2017
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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