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 wheelchair, mechanical
510(k) Number K120628
Device Name HELIO
Applicant
MOTION COMPOSITES
519 J-OSWALD-FOREST
SUITE 101
SAINT-ROCH-DE-L' ACHIGAN,  CA J063H0
Applicant Contact VINCENT LECUYER
Correspondent
MOTION COMPOSITES
519 J-OSWALD-FOREST
SUITE 101
SAINT-ROCH-DE-L' ACHIGAN,  CA J063H0
Correspondent Contact VINCENT LECUYER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/01/2012
Decision Date 12/19/2012
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
-
-