FDA.reportPublic FDA data

Migraine-therapy peripheral nerve electrical stimulator

Definition
A portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls, user display, and metal skin contact surfaces that enable application of the electrical signal intended to provide a localized oscillating electric field; it may be used in conjunction with a smartphone. The device is typically used with conductive gel and may be operated by a patient or healthcare provider in the home and healthcare facility. This is a reusable device.
GUDID devices
90
Last updated
2026-07-17 22:01:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00815203022762gmmaCore - Refill CardelectroCore, Inc.12116-00501-C2026-06-25
00815203022779gammaCore Refill CardelectroCore, Inc.12116-00503-C2026-06-25
00815203022786gammaCore Refill CardelectroCore, Inc.12116-00512-C2026-06-25
00815203022663gammaCore Emerald Replacement Power BlockelectroCore, Inc.12116-04904-RPL2026-01-12
08800020403032DOOPANGYbrain Inc.YPS-301BD2026-03-10
00815203020089gammaCore SapphireelectroCore, Inc.20016-00301-RPL2026-02-16
00815203021864gammaCore SapphireelectroCore, Inc.20016-00501-RPL2026-02-16
00815203022045gammaCore Sapphire electroCore, Inc.13016-04501-C2026-02-16
00815203022052gammaCore SapphireelectroCore, Inc.13016-04502-C2026-02-16
00815203022076gammaCore SapphireelectroCore, Inc.13016-04504-C2026-02-16
00815203022236gammaCore SapphireelectroCore, Inc.12016-049992026-02-16
00815203022441gammaCoreelectroCore, Inc.20016-00003-RPL2026-02-16
00815203022458gammaCoreelectroCore, Inc.20016-00006-RPL2026-02-16
00815203022687gammaCore SapphireelectroCore, Inc.20016-00502-RPL2026-02-16
00815203022694gammaCore EmeraldelectroCore, Inc.20116-00001-RPL2026-02-16
00815203022700gammaCore EmeraldelectroCore, Inc.20116-10301-RPL2026-02-16
00815203022717gammaCore EmeraldelectroCore, Inc.50022-00004-RPL2026-02-16
00815203022724gammaCore EmeraldelectroCore, Inc.50022-00078-RPL2026-02-16
00815203022427gammaCore Sapphire AC Power AdapterelectroCore, Inc.20016-00001-RPL2026-01-28
00815203022472gammaCore Emerald 3-Month Device KitelectroCore, Inc.12116-040032026-01-14
00815203022489gammaCore Emerald 12-Month Device KitelectroCore, Inc.12116-040122026-01-14
00815203022496gammaCore Emerald-D Device KitelectroCore, Inc.12116-040362026-01-14
00815203022502gammaCore Emerald 6-Month Evaluation Device KitelectroCore, Inc.11116-040062026-01-14
00815203022519gammaCore 1-Month Refill KitelectroCore, Inc.12116-045012026-01-14
00815203022526gammaCore 3-Month Refill KitelectroCore, Inc.12116-045032026-01-14
00815203022533gammaCore 12-Month Refill KitelectroCore, Inc.12116-045122026-01-14
00815203022540gammaCore 6-Month Evaluation Refill KitelectroCore, Inc.11116-045062026-01-14
00815203022557gammaCore Emerald 1-Month Licensed Device KitelectroCore, Inc.13116-040012026-01-14
00815203022564gammaCore Emerald 3-Month Licensed Device KitelectroCore, Inc.13116-040032026-01-14
00815203022571gammaCore Emerald 12-Month Licensed Device KitelectroCore, Inc.13116-040122026-01-14
00815203022588gammaCore Emerald 36-Month Licensed Device KitelectroCore, Inc.13116-040362026-01-14
00815203022601gammaCore 1-Month CardelectroCore, Inc.12116-04501-C2026-01-14
00815203022618gammaCore 3-Month CardelectroCore, Inc.12116-04503-C2026-01-14
00815203022625gammaCore 12-Month CardelectroCore, Inc.12116-04512-C2026-01-14
00815203022632gammaCore Emerald Handset - ReplacementelectroCore, Inc.12116-04901-RPL2026-01-14
00815203022649gammaCore Emerald Replacement Charging PadelectroCore, Inc.12116-04902-RPL2026-01-14
00815203022656gammaCore Emerald Replacement USB CableelectroCore, Inc.12116-04903-RPL2026-01-14
00815203020430gammaCore Sapphire DelectroCore, Inc.11016-403022020-05-22
00815203020447gammaCore Sapphire DelectroCore, Inc.11016-403032020-05-22
00815203020454gammaCore Sapphire DelectroCore, Inc.11016-403042020-05-22
00815203020461gammaCore Sapphire DelectroCore, Inc.11016-403052020-05-22
00815203020485gammaCore-S 250electroCore, Inc.11009-400012020-05-22
00815203022465gammaCore Emerald 1-Month Device KitelectroCore, Inc.12116-040012025-09-05
00815203020539gammaCore Sapphire SLC Device KitelectroCore, Inc.12016-040012021-08-04
00815203020546gammaCore Sapphire SLC Device KitelectroCore, Inc.12016-040022021-08-04
00815203020553gammaCore Sapphire SLC DEMO Device KitelectroCore, Inc.12016-040032021-08-04
00815203020560gammaCore Sapphire SLC DEMO Device KitelectroCore, Inc.12016-040042021-08-04
00815203020614gammaCore Sapphire SLC Refill Card KitelectroCore, Inc.12016-045312021-08-04
00815203020621gammaCore Sapphire SLC Refill Card KitelectroCore, Inc.12016-045932021-08-04
00815203021260gammaCore Sapphire Device Starter KitelectroCore, Inc.13016-040012021-08-04
00815203021277gammaCore Sapphire Device Starter KitelectroCore, Inc.13016-040022021-08-04
00815203021284gammaCore Sapphire Device Starter KitelectroCore, Inc.13016-040032021-08-04
00815203021291gammaCore Sapphire Device Starter KitelectroCore, Inc.13016-040042021-08-04
00815203021307gammaCore Sapphire Device Starter KitelectroCore, Inc.13016-040052021-08-04
00815203021314gammaCore Sapphire SLC DEMO Device KitelectroCore, Inc.13016-040062021-08-04
00815203021321gammaCore Sapphire SLC DEMO Device KitelectroCore, Inc.13016-040072021-08-04
00815203021338gammaCore Sapphire SLC DEMO Device KitelectroCore, Inc.13016-040082021-08-04
00815203021345gammaCore Sapphire SLC DEMO Device KitelectroCore, Inc.13016-040092021-08-04
00815203021468gammaCore Sapphire Refill Card KitelectroCore, Inc.13016-045012021-08-04
00815203021475gammaCore Sapphire Refill Card KitelectroCore, Inc.13016-045022021-08-04
00815203021482gammaCore Sapphire Refill Card KitelectroCore, Inc.13016-045032021-08-04
00815203021499gammaCore Sapphire Refill Card KitelectroCore, Inc.13016-045042021-08-04
00815203021505gammaCore Sapphire DEMO Refill Card KitelectroCore, Inc.13016-045052021-08-04
00815203021512gammaCore Sapphire DEMO Refill Card KitelectroCore, Inc.13016-045062021-08-04
00815203021529gammaCore Sapphire DEMO Refill Card KitelectroCore, Inc.13016-045072021-08-04
00815203021734gammaCore Sapphire SLC Device KitelectroCore, Inc.14016-040012021-08-04
00815203021741gammaCore Sapphire SLC Device KitelectroCore, Inc.14016-040022021-08-04
00815203021758gammaCore Sapphire SLC DEMO Device KitelectroCore, Inc.14016-040032021-08-04
00815203021765gammaCore Sapphire SLC DEMO Device KitelectroCore, Inc.14016-040042021-08-04
00815203021772gammaCore Sapphire Refill Card KitelectroCore, Inc.14016-045012021-08-04
00815203021789gammaCore Sapphire Refill Card KitelectroCore, Inc.14016-045022021-08-04
00815203021796gammaCore Sapphire Refill Card KitelectroCore, Inc.14016-045032021-08-04
00815203021802gammaCore Sapphire DEMO Refill Card KitelectroCore, Inc.14016-045042021-08-04
00815203021819gammaCore Sapphire DEMO Refill Card KitelectroCore, Inc.14016-045052021-08-04
00815203021826gammaCore Sapphire SLC DEMO Refill Card KitelectroCore, Inc.12016-045622021-08-04
00815203021833gammaCore Sapphire SLC DEMO Refill Card KitelectroCore, Inc.12016-045942021-08-04
00810011252509JiajianWuxi Jiajian Medical Instrument Co.,Ltd.CMNS2-12018-11-26
00815203020010gammaCore-SelectroCore, Inc.10009-406012017-06-28
00815203020027gammaCore SapphireelectroCore, Inc.10016-403012018-04-06
00815203020034gammaCore SapphireelectroCore, Inc.10016-403022018-04-06