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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 in applying therapeutic deep heat
Product CodeIMJ
Regulation Number 890.5290
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCELERATED CARE PLUS
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
IBRAMED EQUIPAMENTOS MEDICOS
  SUBSTANTIALLY EQUIVALENT 1
PROMEDTEK INC.
  SUBSTANTIALLY EQUIVALENT 1
REGENESIS BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCKY MOUNTAIN BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIATHERM THERAPEUTICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 5 5
2017 2 2
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2
Fire 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Smoking 2 2
Device Operates Differently Than Expected 1 1
Device Inoperable 1 1
Unexpected Therapeutic Results 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
Failure to Power Up 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
Full thickness (Third Degree) Burn 3 3
Burn(s) 2 2
Partial thickness (Second Degree) Burn 2 2
Injury 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DJO, LLC II Oct-15-2015
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