TPLC - Total Product Life Cycle

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Device	full-montage standard electroencephalograph
Regulation Description	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 Code	GWQ
Regulation Number	882.1400
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOSERENITY
	SUBSTANTIALLY EQUIVALENT	1
BIOSERENITY SAS
	SUBSTANTIALLY EQUIVALENT	1
COMPUMEDICS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CUMULUS NEUROSCIENCE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
IMEDISYNC, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROFIELD, INC.
	SUBSTANTIALLY EQUIVALENT	1
SEER MEDICAL PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPARK NEURO, INC.
	SUBSTANTIALLY EQUIVALENT	1
WAVI CO.
	SUBSTANTIALLY EQUIVALENT	1
ZETO, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Sparking	13	14
Smoking	10	10
Temperature Problem	7	7
Melted	7	7
Excessive Heating	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Use of Device Problem	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Device Fell	5	5
Output Problem	4	4
Fire	4	4
Loss of Data	4	4
Circuit Failure	4	4
Crack	3	3
Electro-Static Discharge	3	3
Device Emits Odor	3	3
Overheating of Device	3	3
Electrical /Electronic Property Problem	3	3
Unintended Electrical Shock	2	2
Patient-Device Incompatibility	2	2
Battery Problem	2	2
Communication or Transmission Problem	2	2
Thermal Decomposition of Device	2	2
Sharp Edges	2	2
Detachment of Device or Device Component	2	2
Device Dislodged or Dislocated	2	2
Power Problem	2	3
Appropriate Term/Code Not Available	2	2
Break	2	2
Loose or Intermittent Connection	2	2
Device Markings/Labelling Problem	1	1
Failure to Transmit Record	1	1
Therapeutic or Diagnostic Output Failure	1	1
Patient Device Interaction Problem	1	1
Unable to Obtain Readings	1	1
Failure to Power Up	1	1
Computer Software Problem	1	1
Data Back-Up Problem	1	1
No Display/Image	1	1
Electromagnetic Interference	1	1
Intermittent Shock/Stimulation	1	1
Device Displays Incorrect Message	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	77	78
Blister	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pain	2	2
Unspecified Tissue Injury	2	2
Unspecified Infection	1	1
Sleep Dysfunction	1	1
Memory Loss/Impairment	1	1
Cognitive Changes	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Palpitations	1	1
Insufficient Information	1	1
Suicidal Ideation	1	1
Blurred Vision	1	1
Feeding Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Natus Neurology DBA Excel Tech., Ltd. (XLTEK)	II	Jul-18-2025
2	Nihon Kohden America Inc	II	Jan-14-2021
3	SEER MEDICAL PTY LTD	II	Sep-13-2024
4	WAVi Co.	II	May-31-2024