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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, nerve, peripheral, electric
Regulation Description Electrical peripheral nerve stimulator.
Product CodeKOI
Regulation Number 868.2775
Device Class 2


Premarket Reviews
ManufacturerDecision
BLINK DEVICE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BLINK DEVICE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH - IRVINE
  SUBSTANTIALLY EQUIVALENT 1
IDMED
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SENZIME AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 4 4
2020 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Use of Device Problem 2 2
Output Problem 2 2
Excess Flow or Over-Infusion 2 2
Over-Sensing 2 2
Failure to Select Signal 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Melted 1 1
No Device Output 1 1
Overheating of Device 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Muscle Weakness 2 2
Oversedation 2 2
No Known Impact Or Consequence To Patient 2 2
Suffocation 2 2
No Code Available 2 2
No Patient Involvement 1 1
Not Applicable 1 1
Apnea 1 1
Asphyxia 1 1
Paralysis 1 1
Partial thickness (Second Degree) Burn 1 1
Respiratory Acidosis 1 1

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