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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, iontophoresis, other uses
Regulation Description Iontophoresis device.
Product CodeEGJ
Regulation Number 890.5525
Device Class 2


Premarket Reviews
ManufacturerDecision
DERMADRY LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
HIDROXA MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOP-RANK HEALTH CARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2022 1 1
2023 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dizziness 2 2
Blister 2 2
Burn(s) 2 2
Sleep Dysfunction 1 1
Superficial (First Degree) Burn 1 1
Epilepsy 1 1
Fatigue 1 1
Malaise 1 1
Cognitive Changes 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Viral Infection 1 1
Convulsion/Seizure 1 1
Tinnitus 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LTS Therapy Systems, LLC II Jul-29-2025
2 Tapemark Company III Jan-05-2022
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