FDA.reportPublic FDA data

TMS Coil

Primary DI
06971538581047
Brand
TMS Coil
Company
Shenzhen Yingzhi Technology Co.,Ltd.
Model
MY90A
Device description
Double cone TMS coil,liquid cooling
Published
2024-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWFStimulator, Electrical, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230735000Ultimate rTMS; Yingchi rTMSBrain Ultimate, Inc.2023-09-13OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971538581047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971538581047069715385810476971538581047

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560014166
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971538580033Ultimate rTMSM-30 Ultimate2024-01-16
06971538581054TMS CoilBY90A2024-06-14
06971538581061TMS CoilBY90B2024-06-14
06971538581078TMS CoilBF90A2024-06-14
06971538580019Ultimate rTMSM-100 Ultimate2024-01-16
06971538580026Ultimate rTMSM-50 Ultimate2023-12-21
06971538580040Ultimate rTMSM-10 Ultimate2023-12-21
06971538580149TMS Coil/2023-12-21
06971538580156TMS Coil CoolerTCC-012023-12-21
06971538580163TMS Coil CoolerTCC-022023-12-21
06971538580286Positioning CapLycra-10-202023-12-21
06971538580309Treatment ChairUniversal2023-12-21
06971538580316Coil ArmUniversal2023-12-21
06971538580323TrolleyM12023-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B006NVHS102NONENeurovision Medical Products, Inc.GWF2025-12-18
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
08056446901205NExT StationEB NEURO SPAGWF2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWF2025-05-19
00190376530024SafeOp 3ALPHATEC SPINE, INC.GWF2024-11-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTST2Nerveana+®Neurovision Medical Products, Inc.GWF2023-12-04
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P7T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P852Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P8T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P6D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P6T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P7D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P7T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P8D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P8T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPIC61Nerveäna+®Neurovision Medical Products, Inc.GWF2023-04-11