Device
Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves...
Manufacturer
Bistos Co., Ltd.
Bistos Co., Ltd.
Model: BT-1000
DI: 00887529000502
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves with fine electrical stimulation using extracorporeal electrodes.
The treatment protocol using the BT-1000 is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve via an electrode placed on the forehead. The trigeminal nerve is the largest cranial nerve and has three major sensory divisions of the face, all of which are bilateral.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9252292d-8af6-489d-93c4-1b44079a1a7a
Distribution Status:
In Commercial Distribution
DUNS Number:
689908411
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00887529000502
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60682
Name: Craniofacial analgesia electrical stimulator
Definition:
A 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.
FDA Product Codes
QGL
Transcutaneous Nerve Stimulator For Adhd
Premarket Submissions
Submission Number:
K232991
Supplement Number:
000