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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, Electrical, Percutaneous (Pens), For Pain Relief
510(k) Number K220397
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
Regulation Number882.5890
Classification Product Code
NHI  
Date Received02/11/2022
Decision Date 05/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Clinical Trials NCT03540446
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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