FDA.reportPublic FDA data

HORIZON™ Air Film Coil

Primary DI
05060229532268
Brand
HORIZON™ Air Film Coil
Company
THE MAGSTIM COMPANY LIMITED
Model
4980-00
Published
2017-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBPTranscranial Magnetic Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171051000
K180907000
K182853000
K241518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171051000HORIZON Therapy SystemMagstim Company, Ltd.2017-09-13OBP
K180907000HORIZON TMS Therapy SystemMagstim Company, Ltd.2018-08-03OBP
K182853000HORIZON TMS Therapy SystemMagstim Company, Ltd.2019-03-15OBP
K241518000Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)The Magstim Company Limited2024-08-30OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060229532268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060229532268050602295322685060229532268

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation system, stationaryA stationary assembly of mains electricity (AC-powered) devices intended for the treatment 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 to enhance the therapeutic effect.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441994240798QA.RA@magstim.com
+441994241111salesoperations@magstim.com

Regulatory Flags#

DUNS number
500375274
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060229533074Horizon 3.0 MEP Pod6261-002024-10-30
05060229533081Horizon 3.0 Inspire Mainframe6251-002024-10-30
05060229532701Horizon 3.0 PSU (Power Supply Unit)5801-002021-12-21
05060229532251HORIZON™ MT Remote Coil4990-002017-11-22
05060229532299HORIZON™ User Interface5048-002017-11-22
05060229530455Magstim Rapid² Power Supply Single Module3013-002016-09-23
05060229530479Magstim Rapid² Power Supply Dual Module3014-002016-09-23
05060229531476Magstim Plus1 Module4040-002025-07-10
05060229531513Magstim D70 Alpha Coil4150-002025-07-10
05060229531520Magstim D70 Alpha Flat Coil (Coated)4170-002025-07-10
05060229531803Magstim D60 Alpha Flat Coil (Coated)4190-002025-07-10
05060229531926Magstim Plus1 Module 115V4040-US2025-07-10
05060229531964Magstim D60α Branding Iron (Coated) Coil4189-002025-07-10
05060229531971Magstim D70α Branding Iron (Coated) Coil4510-002025-07-10
05060229530868Magstim Double 70mm Air Film Coil3950-002025-02-19
05060229532411D25 Alpha B.I. Coil5220-002025-02-19
05060229533012Horizon 3.0 Coil Holder5835-00-502025-02-19
05060229533029Horizon 3.0 Camera Stand5471-00-502025-02-19
05060229530448Magstim Rapid² Stimulator3012-002016-09-23
05060229530820Double 70mm Air Film Coil3910-002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHOBP2026-04-09
07290110530136Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
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 LTDOBP2026-03-14
07290110538057Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
04650075333273CloudTMS EdgeNEUROSOFT, OOOOBP2026-01-23
04650075337783CloudTMS EdgeNEUROSOFT, OOOOBP2026-01-23
00850005944935NeuroStar HeadrestNEURONETICS, INC.OBP2025-12-15
05713484020482MagProTonica Elektronik A/SOBP2025-12-11
05713484031181MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
05713484031440MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
05713484031648MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
00850005944881NeuroStar Head Support System, DomesticNEURONETICS, INC.OBP2025-12-09
00850005944898NeuroStar Head Support System, DomesticNEURONETICS, INC.OBP2025-12-09
00850005944911NeuroStar HeadrestNEURONETICS, INC.OBP2025-12-09
00850005944928D-Tect MT AccessoryNEURONETICS, INC.OBP2025-12-09
06430063200194Nexstim NBS White Head TrackerNexstim OyjOBP2025-10-17
06430063200200Nexstim Head Tracker TapeNexstim OyjOBP2025-10-17
00860012355419NQ TMS Applicator ArmNeuroqore, Inc.OBP2025-08-06