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 K962703
Device Name THEE THERMASTIM
Applicant
Ehti Medical Corp.
2391 NE Loop 410, Suite #404
San Antonio,  TX  78217
Applicant Contact JAMES B BINGHAM
Correspondent
Ehti Medical Corp.
2391 NE Loop 410, Suite #404
San Antonio,  TX  78217
Correspondent Contact JAMES B BINGHAM
Regulation Number890.5290
Classification Product Code
IMJ  
Subsequent Product Code
IPF  
Date Received07/12/1996
Decision Date 02/21/1997
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
-
-