ManaMed® FDA Receives Breakthrough Clearance for Compact PlasmaFlow® X System

ManaMed® has announced U.S. Food and Drug Administration (FDA) 510(k) clearance for PlasmaFlow® X, the company’s next-generation tubeless sequential compression system designed to advance recovery and enhance patient mobility. 

Classified as a Class II device, PlasmaFlow® X delivers powerful therapy in a smaller, smarter and longer-lasting design.

Engineered for convenience and efficiency, PlasmaFlow® X features an all-day battery offering twice the life of the previous model, the latest controller architecture and USB-C charging for seamless use across healthcare settings. 

Its expanded LCD display provides instant access to key information, including battery status, pressure levels, patient usage and adherence. 

The system’s low-profile, lightweight sleeve ensures comfort and flexibility for patients at home or on the move.

PlasmaFlow® X has been cleared for use as a compressible limb sleeve device to aid in the prevention of deep vein thrombosis (DVT), reduce post-operative pain and swelling, and promote blood circulation in patients who remain stationary for long periods. 

Its tubeless, compact design supports consistent therapy while reducing storage needs and packaging waste.

This milestone marks a significant step in ManaMed’s decade-long commitment to innovation in patient care and recovery solutions.