Device
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.
Manufacturer
Bistos Co., Ltd.
Bistos Co., Ltd.
Model: N/A
DI: 00887529000519
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
63f6f92d-33c8-4838-9e3e-9abdb7d42d6a
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:
00887529000519
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