• 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
Product CodeILX
Regulation Number 890.5290
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOELECTRONICS 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
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

-
-