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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electromagnetic stimulator, pain relief
Definition Intended to apply a magnetic-field induced electrical current to treat pain.
Product CodeQPL
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
NEURALACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURALACE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Emotional Changes 1 1
Pain 1 1

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