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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, photic, evoked response
Product CodeGWE
Regulation Number 882.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
ANSCHEL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYPTYCH PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSYS LLC
  SUBSTANTIALLY EQUIVALENT 1
DIOPSYS INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFELINES LTD.
  SUBSTANTIALLY EQUIVALENT 1
LKC TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
METROVISION
  SUBSTANTIALLY EQUIVALENT 2
MICROMED S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
VERISCI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VISIONSEARCH PTY LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 2 2
2018 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Sparking 4 4
Thermal Decomposition of Device 2 2
Electrical /Electronic Property Problem 2 2
Material Frayed 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 2 2
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diopsys, Inc. III Apr-26-2010
2 Natus Medical Incorporated II Feb-09-2015
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