4power4-PowerStand

4power4-PowerStand specializes in Class I medical devices focused on patient positioning and support. Their product range includes adjustable patient stands and transfer aids, such as the P4-Crossover, P-Advance, and P-access series, which are designed for clinical, home care, and mobility settings. Other models like the P4-Adventure, P4-Country, and P-eStand cater to specialized needs in different environments, ensuring versatile support for patient transfers and positioning.

4power4-PowerStand is based in Belgium, which places them within the European Union’s regulatory framework. Since their devices fall under Class I of the EU Medical Device Regulation (MDR), they must comply with EU standards, and their products are registered in the EUDAMED database. Operating from Belgium ensures alignment with EU regulatory requirements for these patient support devices.

All of 4power4-PowerStand’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. Since these products are Class I under the MDR, they must be documented in EUDAMED to demonstrate compliance with EU regulatory requirements for medical devices.

4power4-PowerStand’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk devices like patient positioning and support aids, which typically require less stringent regulatory oversight than higher-risk categories. However, even Class I devices must still meet EU safety, performance, and compliance standards before being registered in EUDAMED.