Delta International Services & Logistics S.R.L

Delta International Services & Logistics S.R.L specializes in neuromodulation devices, specifically those using transcutaneous electrical nerve stimulation (TENS) technology. Their portfolio includes the Scrambler Therapy MC-5 and ST-5A models, which are designed to manage pain through non-invasive electrical stimulation.

The company is based in the United States. This location may influence regulatory pathways and compliance requirements for their devices, though individual device authorization depends on the specific regulatory body’s evaluation.

Delta’s neuromodulation devices, such as the Scrambler Therapy MC-5 and ST-5A, are listed in the FDA’s 510(k) registry. This classification indicates they have undergone a premarket notification process to demonstrate substantial equivalence to a predicate device, though it does not imply automatic approval.

The company’s neuromodulation devices, including the Scrambler Therapy MC-5 and ST-5A, fall under Class II classification by the FDA. This classification typically applies to devices with moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.