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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interferential current therapy
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Product CodeLIH
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTAFLEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
THERASIGMA, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2024 1 1
2025 1 1
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Loss of consciousness 2 2
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Burn(s) 1 1
Fall 1 1
Numbness 1 1

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