TMS-Cobot TS MV
by Axilum Robotics France EUDAMED510(k)
510(k) K182768
Product code QFF
Overview
The TMS-Cobot TS MV is an Electromechanical Arm for a Transcranial Magnetic Stimulation System, designed to assist in precise, automated positioning of the TMS coil during neurological assessments. This device integrates with transcranial magnetic stimulation (TMS) equipment to enhance reproducibility and accuracy of stimulation targeting, particularly in clinical and research settings.
The TMS-Cobot TS MV is supplied as a reusable electromechanical device, intended for use in controlled clinical environments such as neurology departments or research laboratories. It operates in conjunction with TMS systems and is regulated under FDA 510(k) clearance (K182768) and MDR/MDD compliance, with a classification as a Class II medical device. Storage and maintenance requirements are manufacturer-specific, adhering to standard electromechanical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK182768 | Date17 Feb 2019 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- QFF
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5805
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Axilum Robotics
Questions
What clinical settings is the TMS-Cobot TS MV intended for use in, and how does it improve the TMS procedure?
The TMS-Cobot TS MV is designed for controlled clinical environments such as neurology departments and research laboratories. It assists in precise, automated positioning of the TMS coil during neurological assessments, which enhances reproducibility and accuracy of stimulation targeting—critical for consistent and reliable TMS therapy or research outcomes.
Is the TMS-Cobot TS MV a single-use or reusable device, and what maintenance considerations should be noted?
The TMS-Cobot TS MV is a reusable electromechanical device, meaning it is intended for repeated use in clinical or research settings. Maintenance requirements follow standard protocols for electromechanical devices, though specific storage and upkeep instructions should be followed as outlined by the manufacturer to ensure proper functionality and longevity.
How does the TMS-Cobot TS MV integrate with existing TMS systems, and what regulatory pathways does it follow?
The TMS-Cobot TS MV is specifically designed to integrate with transcranial magnetic stimulation (TMS) equipment, improving targeting precision and reproducibility. Regulatory-wise, it has received FDA 510(k) clearance (K182768) and complies with both the EU Medical Device Directive (MDD) and the Medical Device Regulation (MDR), classifying it as a Class II medical device.
What types of neurological assessments or research applications is the TMS-Cobot TS MV particularly suited for?
While the device itself does not specify clinical indications, its design—enhancing precise coil positioning—makes it particularly useful in neurological assessments and research involving TMS, such as mapping brain function, studying motor cortex excitability, or evaluating treatment responses in conditions like depression, epilepsy, or movement disorders.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K182768
- EUDAMED