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 Interferential Current Therapy
510(k) Number K003631
Device Name SMARTWAVE IF 2000
Applicant
Newwave Medical, LLC
620 Haggard St.
Suite 614
Plano,  TX  75074
Applicant Contact ROBERT ARMSTRONG
Correspondent
Newwave Medical, LLC
620 Haggard St.
Suite 614
Plano,  TX  75074
Correspondent Contact ROBERT ARMSTRONG
Regulation Number882.5890
Classification Product Code
LIH  
Date Received11/24/2000
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-