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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, auditory, evoked response
Regulation Description Evoked response auditory stimulator.
Product CodeGWJ
Regulation Number 882.1900
Device Class 2


Premarket Reviews
ManufacturerDecision
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
PATH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
VIVOSONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 8 8
2023 6 6
2024 7 7
2025 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Sparking 9 9
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Component or Accessory Incompatibility 2 2
Fire 2 2
Insufficient Information 2 2
Smoking 2 2
Melted 2 2
Material Frayed 1 1
False Negative Result 1 1
Unintended Electrical Shock 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unable to Obtain Readings 1 1
Failure to Power Up 1 1
Data Problem 1 1
Failure to Reset 1 1
Electrical /Electronic Property Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Hearing Impairment 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Burn(s) 1 1
Pain 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PATH II Dec-18-2025
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