Magstim Quality & Regulatory

Magstim is driven to make healthcare better for customers by providing innovative products and services that meet regulatory requirements through our effective quality system.

Aligning closely with our mission and values, we define quality at our organisation through this policy. We stand behind our products and address issues if they arise. To support this, we have a robust quality management system (QMS) certified to MDSAP ISO 13485, to enable collaboration and global agility, maximises efficiency and ensures compliance to local legislative requirements. The Magstim Company Ltd. is committed to delivering high-quality products to customers – this starts with designing quality into our processes and products.

Magstim aims to ensure that our products meet the highest standards of safety and quality. From initial development stages to market entry and ongoing compliance, to ensure our devices adhere to all applicable laws and regulations. With a focus on transparency and diligence, we are committed to upholding the integrity of our products and bring innovative TMS solutions to researchers and patients.

Regulatory Indications

USA – FDA Cleared Indications For Use

Magstim Double 70mm Air Film Coil

The Magstim Double 70mm Air Film Coil is a stimulating coil solely intended for use with the Magstim Rapid Stimulating Unit for the purposes of peripheral nerve stimulation. The coil is an accessory of the Magstim Rapid Unit.

Magstim Double 70mm Coil

The Magstim Double 70mm Coil is a stimulating coil intended for use with the Magstim200 Stimulating Unit or the Magstim Rapid Stimulating Unit for the purpose of peripheral nerve stimulation for diagnostic purposes. The coil is an accessory of the Magstim Rapid Unit.

Magstim 2002 TMS System

Magstim 2002 is indicated for Stimulation of Peripheral Nerves for Diagnostic use. All other uses are  investigational use only.

HORIZON® TMS Systems

The HORIZON® TMS Systems are indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

HORIZON3.0 ® TMS Systems

Horizon 3.0 TMS Therapy System(s) are indicated for the treatment of Major Depressive Disorder, and decreasing co-morbid anxiety symptoms where present, in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Bistim2 TMS System

Not cleared under 510k. Classed as Investigational device. Limited by United States Federal law to investigational use

Super Rapid² Plus1 TMS System

Not cleared under 510k. Classed as Investigational device. Limited by United States Federal law to investigational use

The use of Magstim devices for other than FDA cleared intended uses is considered investigational. In accordance with US federal regulations, an IDE and/or IRB approval may be required for use of Magstim devices for uses distinct from the FDA cleared Indication(s) for Use. The sponsor is responsible for obtaining appropriate, required approvals. please consult FDA’s website (www.fda.gov) for more information. All investigational devices must be labelled in accordance with the labelling provisions of the IDE regulation (§ 812.5) and must bear a label with this statement:

“CAUTION Investigational Device. Limited by Federal (or United States) law to investigational use.”

EU Medical Device Directive (CE01082) Indications For Use

Magstim 2002 and Bistim2 TMS Systems

Magstim2002 and Bistim2 and Magstim Class II Research and Therapy Coils are indicated for stimulation of the human cortex to generate Motor Evoked Potentials, for use as an aid prognosis of motor function recovery in stroke patients.

Magstim Class IIa Research and Therapy Coils

Magstim Class IIa Research & Therapy Coils are class IIa active devices, intended for use with their compatible TMS System(s) to allow the system to perform as intended by the manufacturer.

For use in research, Magstim Class IIa Research & Therapy Coils may be used with the following systems:

Magstim 200 & BiStim TMS Systems
Magstim Rapid TMS Systems (Standard Rapid, Super Rapid, Super Rapid Plus 1)

Rapid TMS Systems

The Rapid TMS System when used together with AFC Coil and MT Coil are indicated for;

Treatment of Major Depressive Disorder (MDD).
Treatment of/decreasing of Anxiety Symptoms.
Treatment of Obsessive-Compulsive Disorder (OCD)

Horizon TMS Systems

The Horizon TMS Systems when used with its compatible coils are indicated for;

Treatment of Major Depressive Disorder (MDD).
Treatment of/decreasing of Anxiety Symptoms.
Treatment of Obsessive-Compulsive Disorder (OCD)

EU Medical Device Regulation (MDR780540) Indications For Use (Pending)

Magstim 2002 and Bistim2 TMS Systems

Magstim Class IIa Research and Therapy Coils

Magstim Class IIa Research & Therapy Coils are class IIa active devices, intended for use with their compatible TMS System(s) to allow the system to perform as intended by the manufacturer.

For use in research, Magstim Class IIa Research & Therapy Coils may be used with the following systems:

Magstim 200 & BiStim TMS Systems

Magstim Rapid TMS Systems (Standard Rapid, Super Rapid, Super Rapid Plus 1)

Rapid TMS Systems

The Rapid TMS System when used together with AFC Coil and MT Coil are indicated for;

Treatment of Major Depressive Disorder (MDD).
Treatment of/decreasing of Anxiety Symptoms.
Treatment of Obsessive-Compulsive Disorder (OCD)

Horizon TMS Systems

The Horizon TMS Systems when used with its compatible coils are indicated for;

Treatment of Major Depressive Disorder (MDD).
Treatment of/decreasing of Anxiety Symptoms.
Treatment of Obsessive-Compulsive Disorder (OCD)

Horizon 3.0 TMS Systems

The Horizon 3.0 TMS Systems when used with its compatible coils are indicated for;

Treatment of Major Depressive Disorder (MDD).
Treatment of/decreasing of Anxiety Symptoms.
Treatment of Obsessive-Compulsive Disorder (OCD)

Uk Medical Device Regulation (UKCA 768240) Indications For Use

Magstim 2002 and Bistim2 TMS Systems

Magstim Class IIa Research and Therapy Coils

Magstim Class IIa Research & Therapy Coils are class IIa active devices, intended for use with their compatible TMS System(s) to allow the system to perform as intended by the manufacturer.

For use in research, Magstim Class IIa Research & Therapy Coils may be used with the following systems:

Magstim 200 & BiStim TMS Systems
Magstim Rapid TMS Systems (Standard Rapid, Super Rapid, Super Rapid Plus 1)

Rapid TMS Systems

The Rapid TMS System when used together with AFC Coil and MT Coil are indicated for;

Treatment of Major Depressive Disorder (MDD).
Treatment of/decreasing of Anxiety Symptoms.
Treatment of Obsessive-Compulsive Disorder (OCD)

Horizon TMS Systems

The Horizon TMS Systems when used with its compatible coils are indicated for;

Treatment of Major Depressive Disorder (MDD).
Treatment of/decreasing of Anxiety Symptoms.
Treatment of Obsessive-Compulsive Disorder (OCD)

Horizon 3.0 TMS Systems

The Horizon 3.0 TMS Systems when used with its compatible coils are indicated for;

Treatment of Major Depressive Disorder (MDD).
Treatment of/decreasing of Anxiety Symptoms.
Treatment of Obsessive-Compulsive Disorder (OCD)

Canadian Medical Device Regulation Indications For Use

Magstim 2002 and Bistim2 TMS Systems

Magstim2002 and Bistim2 and Magstim Class II Research and Therapy Coils are indicated for use as a nerve stimulator with built-in evoked potential recording. Intended for assessment of neurological and muscular function in adult populations.

Magstim Class IIa Research and Therapy Coils

Magstim Class IIa Research & Therapy Coils are class IIa active devices, intended for use with their compatible TMS System(s) to allow the system to perform as intended by the manufacturer.

For use in research, Magstim Class IIa Research & Therapy Coils may be used with the following systems:

Magstim 200 & BiStim TMS Systems
Magstim Rapid TMS Systems (Standard Rapid, Super Rapid, Super Rapid Plus 1)

Rapid TMS Systems (MDL69773)

Rapid TMS Systems are indicated for use as a nerve stimulator with built-in evoked potential recording. Intended for assessment of neurological and muscular function in adult populations.

Horizon TMS Systems (MDL102253)

Horizon TMS Systems are indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Furthermore, it is intended to be used for the stimulation of peripheral nerves and the human cortex for the investigation of anatomy, physiology and potential therapeutic effects.