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

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

MDR Year MDR Reports MDR Events
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Charge 1 1
Overheating of Device 1 1

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

-
-