Sooma Oy

Sooma Oy manufactures transcutaneous direct current stimulation (tDCS) devices, which include reusable and disposable electrode systems. These include products like the ComfoCable, various models of ComfoCap (such as CCM3, CCS2, and CCL0), ComfoTrode, ComfoLeads, ComfoPad, and the Sooma DUO. These devices are designed to deliver non-invasive electrical stimulation for therapeutic applications, such as treating depression and chronic pain, in both clinical and home-use settings.

Sooma Oy is based in Finland. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

Sooma Oy’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices under EU regulations. This ensures transparency and compliance with EU medical device requirements.

Sooma Oy’s devices are classified under EU medical device regulations as either Class I or Class IIa. The classification depends on factors like the intended use, risk level, and how the device is applied (e.g., non-invasive or invasive). Class I devices are generally low-risk, while Class IIa devices carry a slightly higher risk but are still considered low to moderate.