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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
IVIVI HEALTH SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
REGENESIS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Diarrhea 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1
Nausea 1 1
Blurred Vision 1 1
Dizziness 1 1
Malaise 1 1
Sensitivity of Teeth 1 1
Confusion/ Disorientation 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Regenesis Biomedical Inc II Jan-26-2009
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