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 Pad, Heating, Powered
510(k) Number K142228
FOIA Releasable 510(k) K142228
Device Name Heated Eye Pad
Applicant
Digital Heat Corporation
5626 S. Captain Kidd Ct. Unit B
Tempe,  AZ  85283
Applicant Contact John Devine
Correspondent
Digital Heat Corporation
5626 S. Captain Kidd Ct. Unit B
Tempe,  AZ  85283
Correspondent Contact John Devine
Regulation Number890.5740
Classification Product Code
IRT  
Date Received08/13/2014
Decision Date 02/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-