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, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K163393
Device Name Hi-Dow Wireless TENS/EMS System (Model HD-SN)
Applicant
Hi-Dow International, Inc.
2555 Metro Blvd
Maryland Heights,  MO  63043
Applicant Contact Eric Chen
Correspondent
Benjamin L. England & Associates, LLC
810 Landmark Drive, Suite 126
Glen Burnie,  MD  21061
Correspondent Contact Schevon G. Salmon
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received12/02/2016
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
-
-