FDA.reportPublic FDA data

EXOMIND Dual applicator

Primary DI
B108699APM1MUS00
Brand
EXOMIND Dual applicator
Company
BTL INDUSTRIES LIMITED
Model
BTL-699-AP-M-1
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OBPTranscranial Magnetic Stimulator
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive DisorderNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B108699APM1MUS00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation systemAn assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools.

Regulatory Flags#

DUNS number
733532951
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B108499AP1MRA1MUS00Large applicator499-AP-MRA-12026-10-20
B108499AP1MRA2MUS00Small applicator499-AP-MR-22026-10-20
B108499AP1MRA45MUS00Edge applicators499-AP-MRA-4, 499-AP-MRA-52026-10-20
B108499PO1MUS00BTL-499-1BTL-499-12026-10-20
B108890APMMUS00EMFACE controllerBTL-785-72026-10-12
B108890APSMUS00EXION Face applicatorBTL-785-22026-10-12
B108398AP1MA3MUS00Chair Applicator398-AP-MA-32026-08-27
B108398PO11MUS00EMSELLA DUOEMSELLA DUO2026-08-27
B108890POAMUS00BTL-890UBTL-890U2026-08-26
B108660POMUS00R-GAITR-GAIT2026-03-19
B108899PO11C1ENUS0150EMSCULPT NEOEMSCULPT NEO2024-09-23
B108043POEMVMUS00EMVITALEMVITAL2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorEMVITAL Hands-Free Applicator2025-11-19
B108785APMMUS10EMFACE controllerBTL-785-72023-06-28
B108699PO3M2MUS00BTL-699 EXOMINDBTL-699 EXOMIND2025-04-04
B108699BELTMEU00BeltBelt2024-11-06
B108699HEADRESTMEU00HeadrestHeadrest2024-11-06
B108699APM2MUS00EXOMIND applicatorBTL-699-AP-M-22024-08-28
B108699PO2M2MUS00EXOMINDEXOMIND2024-08-28
B108043PO30WMUS00LS-6000LS-60002024-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713484030245MagPro AccessoriesTonica Elektronik A/SOBP2026-10-23
05713484031754MagPro AccessoriesTonica Elektronik A/SOBP2026-10-23
10850005944963Hygiene Barrier, 50 PackNEURONETICS, INC.QCI2026-10-21
10850005944963Hygiene Barrier, 50 PackNEURONETICS, INC.OBP2026-10-21
10850005944970Strap, Head PositioningNEURONETICS, INC.QCI2026-10-21
10850005944970Strap, Head PositioningNEURONETICS, INC.OBP2026-10-21
G792699APM21MUS00EXOMIND applicatorBTL INDUSTRIES FZEOBP2026-10-09
G792699HEADREST1MUS00HeadrestBTL INDUSTRIES FZEOBP2026-10-09
G792699PO2M21MUS00EXOMINDBTL INDUSTRIES FZEOBP2026-10-09
06971538581788NeuronavigatorShenzhen Yingzhi Technology Co.,Ltd.OBP2026-08-21
07290110537111Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHQCI2026-04-09
04260526050118Apollo TMS ProMAG & More GmbHOBP2026-04-09
07290110530136Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533083Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533090Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533106Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533113Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110537234Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538026Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538057Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14