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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, nerve, battery-powered
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
XAVANT TECHNOLOGY (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2021 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Detachment Of Device Component 1 1
Noise, Audible 1 1
Inflation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Muscle Weakness 1 1
Itching Sensation 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc II Jun-11-2024
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