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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ultrasonic diathermy for use in applying therapeutic deep heat
Product CodeIMI
Regulation Number 890.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 1
BONUTTI RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRH MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARCI INDUSTRIA E COMERCIO DE APARELHOS CIRURGICOS E ORTO
  SUBSTANTIALLY EQUIVALENT 1
ENRAF-NONIUS, B.V.
  SUBSTANTIALLY EQUIVALENT 1
GENERAL PROJECT S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
IBRAMED EQUIPAMENTOS MEDICOS
  SUBSTANTIALLY EQUIVALENT 1
IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI
  SUBSTANTIALLY EQUIVALENT 1
ITO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
METRON MEDICAL AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUN-RAIN SYSTEM CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 2 2
2017 6 6
2019 7 7
2020 5 5
2021 4 4
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Break 3 3
Insufficient Information 3 3
Patient Device Interaction Problem 3 3
Smoking 2 2
Sparking 1 1
Patient-Device Incompatibility 1 1
Communication or Transmission Problem 1 1
Device Operates Differently Than Expected 1 1
Material Integrity Problem 1 1
Overheating of Device 1 1
Power Conditioning Problem 1 1
Output Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 6 6
Partial thickness (Second Degree) Burn 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Injury 3 3
Electric Shock 2 2
Full thickness (Third Degree) Burn 2 2
No Consequences Or Impact To Patient 2 2
Pain 2 2
Patient Problem/Medical Problem 2 2
No Known Impact Or Consequence To Patient 2 2
Rash 1 1
Swelling 1 1
Tinnitus 1 1
Burning Sensation 1 1
Tingling 1 1
Discomfort 1 1
Hearing Loss 1 1
Lead(s), Burn(s) From 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
No Patient Involvement 1 1
Ambulation Difficulties 1 1

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