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510(k) Data Aggregation
K Number
K223729Device Name
FLOWpresso
Manufacturer
Medella Health Limited
Date Cleared
2023-12-21
(373 days)
Product Code
IRP, IRT
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Medella Health Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat postsurgical medical and/or surgical conditions for which localized thermal therapy are indicated.
Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.
Device Description
The Flowpresso Compression Device is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction, prescription, or supervision of a licensed healthcare professional.
Flowpresso is a non-invasive physical suit that delivers compression, and heat therapy. The suit has air pressure and heat cables that are connected to a computerized power unit that controls ranges and duration of treatment.
The Flowpresso consists of various inflatable wraps that cover the back/hip and extremities of a fully clothed patient with Velcro fasteners. These multi patient use garments are designed to accommodate different anatomical shapes and sizes of patients that can be cleaned and disinfected in between uses to be reused for different patients. The suit has 22 individual internal chambers that inflate sequentially before its predecessor completely deflates, to provide a progressive pressure without any flow back.
Flowpresso is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust the monitor treatment times, temperature, and compression settings. Flowpresso has two separate modes: sports or relaxation, with different cycles to deliver a specific and individual experience that is supervised by a health care provider. The therapy lasts forty (40) minutes where the health provider will be available to make any adjustments throughout the duration of therapy.
The session begins with air pressure to give the patient a comfortable increased pressure, followed by heat. The health care provider is responsible for adjusting settings of pressure/heat to ensure the patient is comfortable for the entirety of the forty (40) minute session.
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