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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
510(k) Number K171366
Device Name Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
Applicant
Stimwave Technologies Inc., Dba Stimq, LLC
901 E Las Olas Blvd., Suite 201
Fort Lauderdale,  FL  33301
Applicant Contact Elizabeth Greene
Correspondent
Stimwave Technologies Inc., Dba Stimq, LLC
901 E Las Olas Blvd., Suite 201
Fort Lauderdale,  FL  33301
Correspondent Contact Elizabeth Greene
Regulation Number882.5870
Classification Product Code
GZF  
Date Received05/09/2017
Decision Date 08/04/2017
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
Recalls CDRH Recalls
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