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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
Regulation Description Ultrasonic diathermy.
Product CodeIMI
Regulation Number 890.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
CARCI INDUSTRIA E COMERCIO DE APARELHOS CIRURGICOS E ORTO
  SUBSTANTIALLY EQUIVALENT 1
ENRAF-NONIUS, B.V.
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 4 4
2022 1 1
2024 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Break 2 2
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Use of Incorrect Control/Treatment Settings 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Burn(s) 3 3
Skin Inflammation/ Irritation 1 1
Inflammation 1 1
Blister 1 1
Discomfort 1 1
Pain 1 1
Ambulation Difficulties 1 1
Increased Sensitivity 1 1

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