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 Massager, Powered Inflatable Tube
510(k) Number K120166
Device Name COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
Applicant
WON INDUSTRIAL CO.
4568 W. 1ST, STE 104
LOS ANGELES,  CA  90004
Applicant Contact DANIEL NAM
Correspondent
WON INDUSTRIAL CO.
4568 W. 1ST, STE 104
LOS ANGELES,  CA  90004
Correspondent Contact DANIEL NAM
Regulation Number890.5650
Classification Product Code
IRP  
Date Received01/19/2012
Decision Date 05/14/2012
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
Recalls CDRH Recalls
-
-