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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 K161154
Device Name Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
Applicant
Spr Therapeutics, LLC
22901 Millcreek Blvd. Suite 110
Cleveland,  OH  44122
Applicant Contact Kathryn Stager
Correspondent
Sfa Consulting, LLC
200 Park Ave., Unit 111
Minneapolis,  MN  55415
Correspondent Contact Susan Alpert
Regulation Number882.5890
Classification Product Code
NHI  
Date Received04/25/2016
Decision Date 07/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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