• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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 show TPLC since Back to Search Results
Device diathermy, shortwave, for use other than applying therapeutic deep heat
Regulation Description Shortwave diathermy.
Product CodeILX
Regulation Number 890.5290
Device Class 2


Premarket Reviews
ManufacturerDecision
CAERUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HI-DOW INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sensitivity of Teeth 1 1
Dizziness 1 1
Low Blood Pressure/ Hypotension 1 1
Malaise 1 1
Headache 1 1
Blurred Vision 1 1
Confusion/ Disorientation 1 1
Diarrhea 1 1
Nausea 1 1

-
-