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 Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K131926
Device Name THERMOPULSE
Applicant
Ibramed Equipamentos Medicos
18851 NE 29th Ave.
720
Aventura,  FL  33180
Applicant Contact TARA CONRAD
Correspondent
Ibramed Equipamentos Medicos
18851 NE 29th Ave.
720
Aventura,  FL  33180
Correspondent Contact TARA CONRAD
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received06/26/2013
Decision Date 07/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-