• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K100246
Device Name MAX-IF1000
Original Applicant
3010 lbj frwy.
12th floor
dallas,  TX  75234
Original Contact judy burton
Classification Product Code
Date Received01/27/2010
Decision Date 11/24/2010
Decision substantially equivalent (SE)
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No