BT-1000 electrode

Primary DI
00887529000519
Brand
BT-1000 electrode
Company
Bistos Co., Ltd.
Model
N/A
Device description
The BT-1000 electrode is a non-invasive accessory applied to the forehead that delivers low-level electrical pulses from the controller unit to stimulate the trigeminal nerve.
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QGLTranscutaneous Nerve Stimulator For Adhd

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGLTranscutaneous Nerve Stimulator For AdhdNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232991000BT-1000Bistos Co., Ltd.2024-08-28QGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887529000519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887529000519008875290005198875290005190887529000519

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial analgesia electrical stimulatorA non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.

Regulatory Flags#

DUNS number
689908411
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887529000410Hi bebe superBT-150B2026-05-15
00887529000502N/ABT-10002026-05-15
08800012315022Hi bebe superBT-150L2021-06-08
08800012315039Hi bebe superBT-150S2021-06-08
00887529000014Hi-dopBT-200VOSD-14200V-0012016-06-14
00887529000021Hi-bebeBT-200SMKT-200-15012016-06-03
00887529000038Hi-bebeBT-200LMKT-200-15012016-06-01
00887529000045N/ABT-200TMKT-200-15012016-06-14
00887529000052N/ABT-350LMKT-350-15092016-06-03
00887529000069N/ABT-350EMKT-350-15092016-06-03
00887529000083N/ABT-220LOSD-14220-0012016-06-03
00887529000090N/ABT-220COSD-14220-0012016-06-03
00887529000106N/ABT-300OSD-15300-0012016-06-14
00887529000199Hi-bebeBT-200C2018-03-16
00887529000465Duo Double Electric Breast PumpAAA00212021-10-28
08800012345012BiliTouchTMMotif Phototherapy Blanket2021-06-09
18800012345019BiliTouchTMMotif Phototherapy Blanket2021-06-09
08800012345005Infant Phototherapy EquipmentBT-4502021-06-08
18800012315029Hi bebe superBT-150L2021-06-08
18800012315036Hi bebe superBT-150S2021-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887529000502N/ABistos Co., Ltd.QGL2026-05-15