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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device stimulator, nerve, battery-powered
Regulation Description Electrical peripheral nerve stimulator.
Product CodeBXN
Regulation Number 868.2775
Device Class 2


Premarket Reviews
ManufacturerDecision
EASYMED INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1
  1.  K162086  MultiStim ECO

MDR Year MDR Reports MDR Events
2017 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 1 1
Defective Component 1 1
Inflation Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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