Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
510(k) Number K152178
Device Name StimQ Peripheral Nerve Stimulator (PNS) System
Applicant
Stimq, LLC
901 E Las Olas Blvd., Suite 201
Fort Lauderdale,  FL  33301
Applicant Contact ELIZABETH GREENE
Correspondent
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 Received08/04/2015
Decision Date 03/11/2016
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
Recalls CDRH Recalls
-
-