AIROS Medical, Inc., a medical technology manufacturer and designer specializing in compression therapy, today announced it has received two 510(k) regulatory clearances to market medical devices from the U.S. Food and Drug Administration (FDA).
The AIROS 6 Sequential Compression Device system (K172770) is a Class II device that works with leg or arm compression garments to deliver gradient pneumatic compression. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow, encourages extracellular fluid clearance, and reduces swelling.
The AIROS 6 system consists of the device and 6-chambered compression garments. The device provides cycles of compressed air and sequentially inflates the garments from distal (foot or hand) to proximal. The inflation and deflation cycles work to move lymphatic fluid build up in the upper and lower extremities.
The AIROS 8 system (K172779) consists of the device and 8-chambered compression garments. The device operates in the same way as the AIROS 6. However, the AIROS 8 has an additional operating mode – Pressure Mode – which allows the user to change the pressure in each individual chamber of the garment. The AIROS 8 also allows for skipping pressure in one chamber in order to reduce pressure over an ulcer or painful wound.
Both devices are equipped with Lymphedema Preparation Treatment (LPT) modes, which are secondary operating modes that can be used before regular gradient sequential therapy.
The devices’ indications for use are on patients affected by lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema.
The devices’ contraindications include infections in the limbs, including cellulitis without appropriate antibiotic coverage, presence of lymphangiosarcoma, Deep Vein Thrombosis (DVT), inflammatory phlebitis or episodes of pulmonary embolism, Congestive Heart Failure (CHF), and any local conditions in which garments would interfere, including untreated wounds, infected wounds, gangrene, recent skin grafts, or dermatitis.
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