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, muscle, powered
510(k) Number K041063
Device Name SMARTWAVE MS 2000
Applicant
NEWWAVE MEDICAL LLC
620 HAGGARD STREET
STE. 614
PLANO,  TX  75074
Applicant Contact ROBERT ARMSTRONG
Correspondent
NEWWAVE MEDICAL LLC
620 HAGGARD STREET
STE. 614
PLANO,  TX  75074
Correspondent Contact ROBERT ARMSTRONG
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/23/2004
Decision Date 12/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-