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ALTMS Transcranial Magnetic Stimulation System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202537

by REMED Co., Ltd.

Identifiers

510(k) Number
K202537 FDA 510(k)
FDA Product Code
OBP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5805 FDA 510(k)
Regulation Number
882.5805 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ALTMS Transcranial Magnetic Stimulation System is a Class II medical device classified as a Transcranial Magnetic Stimulator. It delivers non-invasive magnetic pulses to stimulate nerve cells in the brain, primarily used for therapeutic applications in neurology, including the treatment of depression and other neurological conditions.

The system is supplied as a reusable medical device and is intended for use in clinical settings. It operates under FDA 510(k) clearance and EU MDR compliance, with multiple registration numbers and FEI codes listed in the regulatory database. The device requires proper training for operation and adherence to manufacturer guidelines for safety and efficacy.

Frequently asked questions

What is the ALTMS Magnetic Stimulation Therapy System primarily used for in clinical settings?

The ALTMS Magnetic Stimulation Therapy System is designed for therapeutic applications in neurology, specifically targeting nerve cells in the brain through non-invasive magnetic pulses. It is primarily associated with the treatment of depression and other neurological conditions, though its exact clinical indications should be confirmed with the manufacturer’s guidelines and local regulatory requirements.

Is the ALTMS system reusable or single-use, and how should it be maintained?

The ALTMS Magnetic Stimulation Therapy System is supplied as a reusable medical device, intended for use in clinical settings. Proper maintenance and adherence to the manufacturer’s instructions are required to ensure safety and efficacy, including regular cleaning and calibration as specified by REMED Co., Ltd.

What regulatory pathways does the ALTMS system follow, and how does this affect its use?

The ALTMS system is cleared under the FDA’s 510(k) pathway (K202537) and complies with the EU Medical Device Regulation (MDR). This means it has undergone evaluation for safety and performance in the respective markets, but clinicians should always verify local regulatory compliance and follow manufacturer guidelines for proper use.

Does the ALTMS system require specialized training for operation, and why?

Yes, the ALTMS system requires proper training for operation as outlined by REMED Co., Ltd. This is because transcranial magnetic stimulation involves precise application of magnetic pulses to the brain, which demands familiarity with safety protocols, patient positioning, and device settings to avoid adverse effects and ensure therapeutic benefits.

How do I identify the correct model or registration number for the ALTMS system in my region?

The ALTMS system has multiple registration numbers and FEI codes listed in regulatory databases, such as 3005205657, 9612389, and others. These vary by country and market, so you should cross-reference the device’s label or packaging with the manufacturer’s documentation or local regulatory databases to confirm the correct model and compliance details for your region.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
REMED Co., Ltd.

Sources (2)

  • FDA 510(k) K202537 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026