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	2
CADWELL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
COMPUMEDICS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CORSCIENCE GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
CUMULUS NEUROSCIENCE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ICE NEUROSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMEDISYNC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDEIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROFIELD, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROVIRTUAL USA, 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	16	17
Smoking	12	12
Detachment of Device or Device Component	11	11
Overheating of Device	9	9
Melted	9	10
Use of Device Problem	9	9
Mechanical Problem	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Temperature Problem	7	7
Excessive Heating	7	7
Break	6	6
Fire	5	5
Loss of Data	5	5
Device Fell	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Circuit Failure	4	4
Output Problem	4	4
Unintended Movement	4	4
Appropriate Term/Code Not Available	4	4
Crack	3	3
Electrical /Electronic Property Problem	3	3
Connection Problem	3	3
Electro-Static Discharge	3	3
Material Integrity Problem	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Device Emits Odor	3	3
Failure to Power Up	3	3
Loose or Intermittent Connection	2	2
Power Problem	2	3
Device Dislodged or Dislocated	2	2
No Apparent Adverse Event	2	2
Product Quality Problem	2	3
Sharp Edges	2	2
Thermal Decomposition of Device	2	2
Battery Problem	2	2
Insufficient Information	2	2
Patient-Device Incompatibility	2	2
Unintended Electrical Shock	2	2
Communication or Transmission Problem	2	2
Solder Joint Fracture	1	1
Data Problem	1	1
Unable to Obtain Readings	1	1
Degraded	1	1
Patient Device Interaction Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Computer Software Problem	1	1
Data Back-Up Problem	1	1
Positioning Problem	1	1
Failure to Transmit Record	1	1
Application Program Freezes, Becomes Nonfunctional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	84	85
No Known Impact Or Consequence To Patient	26	27
No Consequences Or Impact To Patient	9	9
Blister	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Electric Shock	2	2
Not Applicable	2	2
Insufficient Information	2	2
Pain	2	2
Unspecified Tissue Injury	2	2
Lead(s), Burn(s) From	2	2
Unspecified Infection	1	1
Sleep Dysfunction	1	1
Tingling	1	1
No Code Available	1	1
No Information	1	1
Memory Loss/Impairment	1	1
Burn, Thermal	1	1
Cognitive Changes	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Palpitations	1	1
Burn(s)	1	1
Burning Sensation	1	1
No Patient Involvement	1	1
Nerve Damage	1	1
Suicidal Ideation	1	1
Laceration(s)	1	1
Partial thickness (Second Degree) Burn	1	1
Blurred Vision	1	1
Feeding Problem	1	1
Bruise/Contusion	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-18-2025
3	Nihon Kohden America Inc	II	Jan-14-2021
4	SEER MEDICAL PTY LTD	II	Sep-13-2024
5	WAVi Co.	II	May-31-2024