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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device media, coupling, ultrasound
Regulation Description Diagnostic ultrasonic transducer.
Product CodeMUI
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDGECARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN PINGCHUANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HONY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANERKANG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ULTRAST, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 13 32
2022 1 2
2023 2 2
2024 2 3
2025 25 25
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Itching Sensation 26 27
Erythema 26 28
Rash 24 24
Pain 23 23
Bacterial Infection 10 29
Foreign Body Reaction 2 2
Insufficient Information 2 2
Burning Sensation 1 1
Local Reaction 1 1
Caustic/Chemical Burns 1 1
Pneumonia 1 1
Tissue Breakdown 1 1
Skin Disorders 1 1
Superficial (First Degree) Burn 1 1
Burn, Thermal 1 1
Blister 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advance Medical Designs, Inc. II Sep-09-2023
2 Pharmaceutical Innovations, Inc. II Aug-20-2020
3 Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. II Jan-20-2024
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