• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back To Search Results
Device Classification Name wheelchair, standup
510(k) Number K042596
Device Name LSA HELIUM
Original Applicant
10925 beamer #290
houston,  TX  77089
Original Contact stefanie d bankston
Regulation Number890.3900
Classification Product Code
Date Received09/23/2004
Decision Date 01/26/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No