FDA.reportPublic FDA data

Magnetic stimulator DuoMAG XT-NL

Primary DI
08592566471506
Brand
Magnetic stimulator DuoMAG XT-NL
Company
DEYMED Diagnostic s.r.o.
Model
47-150
Catalog number
47-150
Device description
47-150
Published
2023-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered
QPLElectromagnetic Stimulator, Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2
QPLElectromagnetic Stimulator, Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210021000Axon TherapyNeuralace Medical, Inc.2021-06-11QPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592566471506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592566471506085925664715068592566471506

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal107 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 858 229 9218hello@neuralacemedical.com

Regulatory Flags#

DUNS number
495566056
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592566001093Pair of Ear Electrodes Sn (Tin)white, 1.5 m00-1092023-06-12
08592566001109Pair of Ear Electrodes Sn (Tin)white, 15 cm00-1102023-06-12
08592566001116Pair of Ear Electrodes Sn (Tin)blue, 1.5 m00-1112023-06-12
08592566001208Disposable blunted needles50 pcs00-1202023-10-26
08592566419003TruScan Neurofeedback Adapter41-90041-9002023-10-26
08592566431395TruScan LT 24 Neurofeedback headbox43-13943-1392023-10-26
08592566432392TruScan LT 32 Neurofeedback headbox43-23943-2392023-10-26
08592566449000TruScan Neurofeedback optical cable V3.3L44-90044-9002023-10-26
08592566453618Deymed Li-ion Battery3.7V 2500mAh 1665045-3612023-10-26
08592566509001TruScan Neurofeedback Acquisition50-90050-9002023-10-26
08592566509506TruScan Neurofeedback Explorer50-95050-9502023-10-26
08592566639005Ear Electrode Sn (Tin)white, 1.5 m63-9002023-10-26
08592566639012Ear Electrode Sn (Tin)white, 15 cm63-9012023-10-26
08592566639029Ear Electrode Sn (Tin)blue, 1.5 m63-9022023-10-26
08592566639234Headbox Safety Ribbon Cable for Cap Connection50cm63-9232023-10-26
08592566639340EEG cap strapXS (green)63-9342023-10-26
08592566639357EEG cap strapS (yellow)63-9352023-10-26
08592566639364EEG cap strapM (red)63-9362023-10-26
08592566639371EEG cap strapL (blue)63-9372023-10-26
08592566679001FlexiCAP electrode ring - rubberwhite67-9002023-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050168L100 Go SystemBioness Medical, Inc.IPF2025-07-17