• 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 diathermy, shortwave, for use other than applying therapeutic deep heat
510(k) Number K121702
Device Name ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
Original Applicant
ORTHO MEDICAL
200 homer ave.
ashland,  MA  01721
Original Contact david rothkopf
Regulation Number890.5290
Classification Product Code
ILX  
Date Received06/08/2012
Decision Date 05/06/2013
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
-
-