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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
MANAMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K210284  ManaSport
  2.  K222098  ManaSport+

MDR Year MDR Reports MDR Events
2019 7 7
2020 5 5
2021 4 4
2022 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Patient Device Interaction Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Smoking 2 2
Sparking 1 1
Material Split, Cut or Torn 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Power Conditioning Problem 1 1
No Apparent Adverse Event 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Burn(s) 4 4
Patient Problem/Medical Problem 2 2
No Known Impact Or Consequence To Patient 2 2
Pain 2 2
No Consequences Or Impact To Patient 2 2
Electric Shock 1 1
Skin Inflammation/ Irritation 1 1
Blister 1 1
Discomfort 1 1
No Patient Involvement 1 1
Partial thickness (Second Degree) Burn 1 1

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