FDA.reportPublic FDA data

Axilum Robotics

Primary DI
03701354620117
Brand
Axilum Robotics
Company
AXILUM ROBOTICS
Model
TMS-Cobot-2
Catalog number
2-01-01
Device description
Axilum Robotics TMS-Cobot TS MV
Published
2019-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFFElectromechanical Arm For A Transcranial Magnetic Stimulation SystemNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182768000TMS-Cobot TS MVAxilum Robotics2019-02-17QFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701354620117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701354620117037013546201173701354620117

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation system, mobileA mobile (on wheels) assembly of mains electricity (AC-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
263039073
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701354600034Axilum RoboticsADAP-MAGV-CB65A-122-02-182021-10-21
03701354600058Axilum RoboticsTMS-Cobot-22-01-022021-10-21
03701354620285Axilum RoboticsADAP-MAGV-CB65AP-112-02-082020-01-23
03701354620261Axilum RoboticsADAP-MAGV-CB65A-112-02-062019-05-03
03701354630116Axilum RoboticsTMS-Explorer-13-01-012019-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012056811Zeta TMS Navigation SystemZeta Surgical Inc.QFF2026-05-26
06430063200187Nexstim NBS SystemNexstim OyjQFF2025-04-01
03701354600034Axilum RoboticsAXILUM ROBOTICSQFF2021-10-21
03701354600058Axilum RoboticsAXILUM ROBOTICSQFF2021-10-21
03701354620285Axilum RoboticsAXILUM ROBOTICSQFF2020-01-23
03701354620261Axilum RoboticsAXILUM ROBOTICSQFF2019-05-03
03701354630116Axilum RoboticsAXILUM ROBOTICSQFF2019-05-03