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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device audiometer
Regulation Description Audiometer.
Product CodeEWO
Regulation Number 874.1050
Device Class 2


Premarket Reviews
ManufacturerDecision
HEARX SA (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
OTODYNAMICS
  SUBSTANTIALLY EQUIVALENT 1
OTODYNAMICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PATH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 6 7
2023 3 3
2024 2 2
2025 13 13
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 14 14
Fracture 4 4
Excessive Heating 3 3
Noise, Audible 2 2
Component or Accessory Incompatibility 1 1
Output Problem 1 1
Device Markings/Labelling Problem 1 1
Unintended Electrical Shock 1 1
Electro-Static Discharge 1 2
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Battery Problem 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Device Emits Odor 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Melted 1 1
Component Incompatible 1 1
Electrical /Electronic Property Problem 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abrasion 13 13
No Clinical Signs, Symptoms or Conditions 12 13
Insufficient Information 2 2
Tinnitus 2 2
High Blood Pressure/ Hypertension 1 1
Sleep Dysfunction 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PATH II Nov-25-2023
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