Positrigo AG

Positrigo AG specializes in neurostimulation devices, specifically the NeuroLF series. This includes basic, pro, and advanced models, as well as the NeuroLF Seat. These products are designed for non-invasive neuromuscular electrical stimulation, primarily used for muscle activation and rehabilitation purposes.

Positrigo AG is headquartered in Switzerland, as indicated by the country designation (CH). The company’s location influences its regulatory compliance and reporting obligations under Swiss and EU medical device regulations.

Positrigo AG’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. Additionally, some of their products have undergone 510(k) clearance in the United States, meaning they are included in the FDA’s pre-market notification database.

Positrigo AG’s devices fall into different risk categories: Class I, Class II, and Class IIa. Classification determines regulatory requirements, such as conformity assessment procedures, post-market surveillance, and labeling obligations. For example, Class IIa devices typically require additional scrutiny compared to Class I due to their higher perceived risk.

The FDA’s 510(k) clearance process applies to medical devices in the U.S. that are deemed substantially equivalent to a legally marketed predicate device. If Positrigo AG’s devices meet this criterion, they are required to submit a 510(k) premarket notification to the FDA, which then lists them in the database. This ensures the devices meet U.S. safety and effectiveness standards before commercialization.