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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
HALYARD HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTRONIX TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
NEUROMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1
SUNMED LLC
  SUBSTANTIALLY EQUIVALENT 1
XAVANT TECHNOLOGY (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 2
XAVANT TECHNOLOGY (PTY), LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2015 3 3
2017 1 1
2021 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 4 4
Noise, Audible 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Alarm System 1 1
Detachment Of Device Component 1 1
High impedance 1 1
Inflation Problem 1 1
Defective Component 1 1
Failure to Shut Off 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Wound Dehiscence 1 1
Bruise/Contusion 1 1
Erythema 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010
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