FDA.report

Brain-responsive electrical stimulation system

Definition
An assembly of devices designed to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to the detection of abnormal electrical events in the brain for the treatment of neurological disorders (e.g., epilepsy). It consists of a sterile, battery-powered sensing device/stimulator implanted below the scalp; one or more leads, which may be placed on the cortical surface or deep in the brain, and which transmit monitoring data, electrocorticograms and stimulation pulses; telemetric control units for programming the stimulator and/or receiving functional data; and software run on a computing device for analysis and reporting.
GUDID devices
36
Last updated
2024-01-09 08:12:27

Related Product Codes

CodeDeviceSpecialtyClassDevices
PFNImplanted Brain Stimulator For EpilepsyUnknown333
GYCElectrode, CorticalNeurology21
GZLElectrode, DepthNeurology21
PEXSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMicrobiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
07290114064071HaGuide SoftwareALPHA OMEGA ENGINEERING CO. LTD.HaGuide Software2022-11-08
00855547005434NeuroPace® Remote Monitor KitNeuropace, Inc.51072023-11-14
00855547005410Explant KitNeuropace, Inc.EX-01-K2022-02-22
00855547005403Remote Monitor Phone AccessoriesNeuropace, Inc.51042020-09-14
27290114060800Neuro Omega ECOG HeadBox KitALPHA OMEGA ENGINEERING CO. LTD.Neuro Omega ECOG HeadBox Kit2020-05-04
00855547005373Ferrule KitNeuropace, Inc.F-01-K2020-03-16
00855547005380Craniectomy Template KitNeuropace, Inc.CT-01-K2020-03-16
00855547005397Connector Cover KitNeuropace, Inc.CC-01-K2020-03-16
00855547005298NeuroPace® Depth Lead KitNeuropace, Inc.DL-344-10-K2020-03-15
00855547005304NeuroPace® Cortical Strip Lead KitNeuropace, Inc.CL-335-10-K2020-03-15
00855547005311NeuroPace® Cortical Strip Lead KitNeuropace, Inc.CL-325-10-K2020-03-15
00855547005328NeuroPace® Cortical Strip Lead KitNeuropace, Inc.CL-315-10-K2020-03-15
00855547005335NeuroPace® Depth Lead KitNeuropace, Inc.DL-330-10-K2020-03-15
00855547005342NeuroPace® Depth Lead KitNeuropace, Inc.DL-330-3.5-K2020-03-15
00855547005359NeuroPace® Depth Lead KitNeuropace, Inc.DL-344-3.5-K2020-03-15
00855547005366RNS® Neurostimulator KitNeuropace, Inc.RNS-320-K2020-03-10
04251204325642US IVD-Bruker Bacterial Test Standard, 5 TubesBruker Daltonik GmbH86045302017-02-25
00855547005014NeuroPace® Depth Lead KitNeuropace, Inc.DL-344-10-K2014-09-24
00855547005021NeuroPace® Depth Lead KitNeuropace, Inc.DL-344-3.5-K2014-09-24
00855547005038NeuroPace® Depth Lead KitNeuropace, Inc.DL-330-3.5-K2014-09-24
00855547005045NeuroPace® Depth Lead KitNeuropace, Inc.DL-330-10-K2014-09-24
00855547005052NeuroPace® Cortical Strip Lead KitNeuropace, Inc.CL-335-10-K2014-09-24
00855547005069NeuroPace® Cortical Strip Lead KitNeuropace, Inc.CL-325-10-K2014-09-24
00855547005076NeuroPace® Cortical Strip Lead KitNeuropace, Inc.CL-315-10-K2014-09-24
00855547005113WandNeuropace, Inc.W-022014-09-24
00855547005120RNS® Neurostimulator KitNeuropace, Inc.RNS-300M-K2017-12-18
00855547005151Connector Cover KitNeuropace, Inc.CC-01-K2014-09-24
00855547005168Craniectomy Template KitNeuropace, Inc.CT-01-K2014-09-24
00855547005175Ferrule KitNeuropace, Inc.F-01-K2014-09-24
00855547005182NeuroPace® Remote Monitor KitNeuropace, Inc.DTR-300-E-K2014-09-24
00855547005199NeuroPace® Remote Monitor KitNeuropace, Inc.DTR-300-K2014-09-24
00855547005212NeuroPace® Programmer KitNeuropace, Inc.PGM-300-K2014-09-24
00855547005229NeuroPace® Lead Accessory KitNeuropace, Inc.LA-02-K2014-09-24
00855547005243NeuroPace® Remote Monitor KitNeuropace, Inc.51012018-05-18
00855547005267RNS® Neurostimulator KitNeuropace, Inc.RNS-320-K2018-05-18
00855547005274RNS® Tablet KitNeuropace, Inc.50012018-01-15