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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device full-montage standard electroencephalograph
Definition Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Product CodeGWQ
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSERENITY
  SUBSTANTIALLY EQUIVALENT 1
BIOSERENITY SAS
  SUBSTANTIALLY EQUIVALENT 1
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORSCIENCE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
EVOKE NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICE NEUROSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMEDISYNC INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFELINES LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDEIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEMORYMD INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROMED S.P.A
  SUBSTANTIALLY EQUIVALENT 1
MOBILEMEDTEK
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL_TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NEUROELECTRICS BARCELONA S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
NEUROVIRTUAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEER MEDICAL PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
WAVI CO.
  SUBSTANTIALLY EQUIVALENT 1
ZETO, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 17 17
2018 15 15
2019 16 16
2020 30 30
2021 19 19
2022 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 17 17
Detachment of Device or Device Component 14 14
Melted 9 9
Overheating of Device 9 9
Use of Device Problem 9 9
Sparking 9 9
Incorrect Measurement 8 8
Smoking 7 7
Break 6 6
Unintended Movement 5 5
Material Integrity Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Loss of Data 3 3
Excessive Heating 3 3
Crack 3 3
Electrical /Electronic Property Problem 3 3
Fire 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Device Tipped Over 3 3
Patient-Device Incompatibility 2 2
Product Quality Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Loose or Intermittent Connection 2 2
No Display/Image 2 2
Thermal Decomposition of Device 2 2
Unintended Collision 2 2
Temperature Problem 2 2
Connection Problem 2 2
Device Markings/Labelling Problem 2 2
Output Problem 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Device Operates Differently Than Expected 2 2
Device Sensing Problem 2 2
Device Fell 2 2
Complete Loss of Power 1 1
Device Dislodged or Dislocated 1 1
Data Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Failure To Run On AC/DC 1 1
Peeled/Delaminated 1 1
Failure to Power Up 1 1
Material Puncture/Hole 1 1
Component Falling 1 1
Degraded 1 1
Display or Visual Feedback Problem 1 1
Failure to Sense 1 1
Material Separation 1 1
Unable to Obtain Readings 1 1
Vibration 1 1
Device Damaged Prior to Use 1 1
Intermittent Shock/Stimulation 1 1
Solder Joint Fracture 1 1
Battery Problem 1 1
Deformation Due to Compressive Stress 1 1
Communication or Transmission Problem 1 1
Device Stops Intermittently 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 43 43
No Clinical Signs, Symptoms or Conditions 38 38
No Consequences Or Impact To Patient 20 20
Not Applicable 3 3
Electric Shock 2 2
Pain 2 2
Lead(s), Burn(s) From 2 2
Partial thickness (Second Degree) Burn 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Misdiagnosis 1 1
Tingling 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Laceration(s) 1 1
Memory Loss/Impairment 1 1
Nerve Damage 1 1
No Patient Involvement 1 1
Burn, Thermal 1 1
Cognitive Changes 1 1
No Information 1 1
No Code Available 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LIFELINES NEURO COMPANY II Dec-20-2019
2 Natus Neurology DBA Excel Tech., Ltd. (XLTEK) II Jul-28-2018
3 Nihon Kohden America Inc II Jan-14-2021
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